| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | f | Essential/Non essential | Schedule | Registration Type* | Application Type* | Market Authorisation Holder | Category of Medical Product* | This product is intended for* | Generic Name* | Brand Name | Dosage Form* | Pack Size* | Type of Packaging* | Composition of active ingredients with strengths* | Manufacturer* | Marketer | Country of Manufacturer* | Therapeutic Category | Certificate Number | Issue Date | Expiry Date |
2 | 1 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Prochlorperazine Maleate I.P...5mg | Stemetil® MD Tablet | Tablet | 25 x 2 x 10 Tablets | Strip | Each uncoated mouth dissolving tablet contains: Prochlorperazine Maleate I.P...5mg | Abbott India Limited. | India | Antipsychotics | BHU-DRA/ER/B05092 | 17-Mar-20 | 17-Mar-2023 | |
3 | 2 | Non Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Human Allopathic Medicine | Human Use | Loratadine USP...5mg | ORADIN Suspension | Suspension | 60 ml | Amber Glass Bottle | Each 5 ml contains: Loratadine USP...5mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Antiallergics and medicines used in anaphylaxis | BHU-DRA/ER/B05090 | 17-Mar-20 | 17-Mar-2023 | ||
4 | 3 | Essential Medicine | A1 | Full Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Cetirizine Hydrochloride BP...10mg | NOSEMIN Tablets | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Cetirizine Hydrochloride BP...10mg | The IBN SINA Pharmaceutical Industry Ltd., Shafipur, Kaliakoir, Gazipur, Bangladesh. | Bangladesh | Antiallergics and medicines used in anaphylaxis | BHU-DRA/B05091 | 17-Mar-20 | 17-Mar-2023 | |
5 | 4 | Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Cetirizine Dihydrochloride BP...10mg | Cetrigen Tablet | Tablet | 1000 Tablets | HDPE Container | Each film coated tablet contains: Cetirizine Dihydrochloride BP...10mg | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antiallergics and medicines used in anaphylaxis | BHU-DRA/ER/B05089 | 17-Mar-20 | 17-Mar-2023 | |
6 | 5 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Cholecalciferol IP…….. 60000 IU(In nano Droplet form)In a flavoured sugar free base…q.s., Excipients...q.s | Arachitol Nano Solution. | Solution | 2 x 5 ml | Amber coloured bottle | Each 5 ml syrup contains: Cholecalciferol IP…….. 60000 IU(In nano Droplet form)In a flavoured sugar free base…q.s., Excipients...q.s | PULSE Pharmaceuticals Pvt. Ltd | India | Vitamins and minerals | BHU-DRA/ER/B05088 | 11-Mar-20 | 11-Mar-2023 | |
7 | 6 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Sildenafil Citrate equivalent to Sildenafil...100mg | ORFORCE 100 Tablet | Tablet | 1 x 4 Tablets | Alu-PVC Blister | Each film coated tablet contains: Sildenafil Citrate equivalent to Sildenafil...100mg | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Medicines for erectile dysfunction | BHU-DRA/ER/B05086 | 11-Mar-20 | 11-Mar-2023 | |
8 | 7 | Essential Medicine | A1 | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Paracetamol IP…500mg, Excipients…q.s | POLYMOL Tablets | Tablet | 20x15 Tablets | Alu-PVC Blister | Each uncoated tablet contains: Paracetamol IP…500mg, Excipients…q.s | SCOTT-EDIL PHARMACIA, Himachal Pradesh, India. | India | Non-opioid Analgesics | BHU-DRA/B05085 | 11-Mar-20 | 11-Mar-2023 | |
9 | 8 | Essential Medicine | B | Full Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Omeprazole Sodium BP Eq. to Omeprazole…40mg | AUDURAS Injection | Powder for Injection | 1 Vial | Vial | Each vial contains: Omeprazole Sodium BP Eq. to Omeprazole…40mg | Accelius Global, Gujarat, India. | India | Antiulcer | BHU-DRA/B05084 | 11-Mar-20 | 11-Mar-2023 | |
10 | 9 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Pinus roxburghil...10mg, Vitamins: Vitamin C...40mg, Vitamin B3...12mg,Vitamin E...10mg, Vitamin B5...5mg, Vitamin B6...2mg, Vitamin B2...1.1mg, Vitamin B1...1mg, Vitamin A...600mcg, Folic acid...100mcg, Biotin...30mcg, Vitamin B12...1mcg, Minerals: Zinc...10mg, Manganese...2mg, Copper...0.9mg, Selenium...40mcg | Becomax® C Forte | Tablet | 15 x 15 N Tablets | Strip | Each serving per film coated tablet contains (approx.): Pinus roxburghil...10mg, Vitamins: Vitamin C...40mg, Vitamin B3...12mg,Vitamin E...10mg, Vitamin B5...5mg, Vitamin B6...2mg, Vitamin B2...1.1mg, Vitamin B1...1mg, Vitamin A...600mcg, Folic acid...100mcg, Biotin...30mcg, Vitamin B12...1mcg, Minerals: Zinc...10mg, Manganese...2mg, Copper...0.9mg, Selenium...40mcg | Tirupati Lifesciences, Nahan Road, Paonta Sahib, Dist. Sirmour (H.P.) - 173 025, India. | India | Vitamins and minerals | BHU-DRA/ER/B05087 | 11-Mar-20 | 11-Mar-2023 | |
11 | 10 | Essential Medicine | B | Full Registration | Generic Drug Application | Vetline Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Fluconazole IP…150mg, Excipients…q.s | FLEZIS-150 | Tablet | 20x1x1 | Alu-PVC Blister | Each uncoated tablet contains: Fluconazole IP…150mg, Excipients…q.s | Grampus Laboratories, Johron, Kalaamb, Sirmour (HP), India | India | Antifungal | BHU-DRA/B05083 | 11-Mar-20 | 11-Mar-2023 | |
12 | 11 | Essential Medicine | A1 | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Silver Sulphadiazine I.P...1%w/w, Chlorhexidine Gluconate Solution I.P eq. To Chlorhexidine Gluconate...0.6% w/w, In a cream base...q.s | BURN NIL Cream | Cream | 50 g | Collapsible Lami tube | Composition: Silver Sulphadiazine I.P...1%w/w, Chlorhexidine Gluconate Solution I.P eq. To Chlorhexidine Gluconate...0.6% w/w, In a cream base...q.s | SCOTT-EDIL PHARMACIA, Himachal Pradesh, India. | India | Antibacterial | BHU-DRA/B05078 | 10-Mar-20 | 10-Mar-2023 | |
13 | 12 | Non Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Promethazine Hydrochloride I.P...5mg, Flavoured Syrupy Base...q.s | ORBIPRO Syrup | Syrup | 60 ml | Amber coloured bottle | Each 5 ml contains: Promethazine Hydrochloride I.P...5mg, Flavoured Syrupy Base...q.s | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Antiallergics and medicines used in anaphylaxis | BHU-DRA/ER/B05068 | 10-Mar-20 | 10-Mar-2023 | |
14 | 13 | Non Essential Medicine | A1 | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Povidone-Iodine I.P...5%w/w(available Iodine 0.5% w/w), Water-soluble ointment base...q.s | POVIMAX Ointment | Ointment | 20 g | Collapsible Lami tube | Composition: Povidone-Iodine I.P...5%w/w(available Iodine 0.5% w/w), Water-soluble ointment base...q.s | SCOTT-EDIL PHARMACIA, Himachal Pradesh, India. | India | Antiseptics | BHU-DRA/B05077 | 10-Mar-20 | 10-Mar-2023 | |
15 | 14 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Phenytoin Sodium IP … 100 mg, Excipients…Q.S | ORBITOIN Tablets | Tablet | 100 Tablets | HDPE Jar | Each film coated tablet contains: Phenytoin Sodium IP … 100 mg, Excipients…Q.S | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Anticonvulsant/ Antiepileptics | BHU-DRA/ER/B05076 | 10-Mar-20 | 10-Mar-2023 | |
16 | 15 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Metoclopramide Hydrochloride I.P. Equivalent to Anhydrous Metoclopramide Hydrochloride...5mg | ORAMIDE Syrup | Syrup | 30 ml | Amber coloured bottle | Each 5ml contains: Metoclopramide Hydrochloride I.P. Equivalent to Anhydrous Metoclopramide Hydrochloride...5mg | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Antiemetic | BHU-DRA/ER/B05069 | 10-Mar-20 | 10-Mar-2023 | |
17 | 16 | Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Dried Ferrous Sulfate USP...150 mg, Folic Acid...500 mcg | FEOFOL Capsules | Capsule | 90 Capsules | Alu-PVDC Blister | Each timed release capsule contains: Dried Ferrous Sulfate USP...150 mg, Folic Acid...500 mcg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Vitamins and minerals | BHU-DRA/ER/B05074 | 10-Mar-20 | 10-Mar-2023 | |
18 | 17 | Non Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ferric Ammonium Citrate I.P...160mg, (equivalent to Elemental Iron 32.8mg), Cyanocobalamin I.P....7.5mcg, Folic Acid I.P...0.5mg, Alcohonol(95%) I.P...0.87mL | DEXORANGE Syrup | Syrup | 200 ml | Amber Glass Bottle | Each 15ml (one tablespoonful) contains: Ferric Ammonium Citrate I.P...160mg, (equivalent to Elemental Iron 32.8mg), Cyanocobalamin I.P....7.5mcg, Folic Acid I.P...0.5mg, Alcohonol(95%) I.P...0.87mL | STP PHARMACEUTICALS PVT LTD. Sangkhola, Singtam, East SIKKIM -737 134, SIKKIM | India | Vitamins and minerals | BHU-DRA/ER/B05075 | 10-Mar-20 | 10-Mar-2023 | |
19 | 18 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Glycerin I.P...85% w/w | n/a | Suppository | 4g x 50 Suppositories | HDPE Jar | Composition: Glycerin I.P...85% w/w | Arora Pharmaceuticals Pvt. Ltd. | India | Laxatives | BHU-DRA/ER/B05067 | 10-Mar-20 | 10-Mar-2023 | |
20 | 19 | Non Essential Medicine | A1 | Full Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Part I: Each 1000mL contains: Potassium Chloride I.P...6.00gms, Magnesium Chloride I.P...3.70gms, Calcium Chloride I.P...8.10gms, Sodium Chloride I.P...178.50gms, Glacial Acetic Acid B.P...9.46gms, Purified water I.P...Q.S Part II: Each 1000mL contains: Sodium Bicarbonate I.P...59.20gms, Sodium Chloride I.P...23.50gms | n/a | Solution and Powder | 10 Litres Can | HDPE jar and Sachet | Composition: Part I: Each 1000mL contains: Potassium Chloride I.P...6.00gms, Magnesium Chloride I.P...3.70gms, Calcium Chloride I.P...8.10gms, Sodium Chloride I.P...178.50gms, Glacial Acetic Acid B.P...9.46gms, Purified water I.P...Q.S Part II: Each 1000mL contains: Sodium Bicarbonate I.P...59.20gms, Sodium Chloride I.P...23.50gms | Atlantic Biomedical Pvt. Ltd. | India | Vitamins and minerals | BHU-DRA/B05081 | 10-Mar-20 | 10-Mar-2023 | |
21 | 20 | Essential Medicine | A1 | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Cetirizine Hydrochloride I.P...10mg, Excipients...q.s | Cetifar | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Cetirizine Hydrochloride I.P...10mg, Excipients...q.s | SCOTT-EDIL PHARMACIA, Himachal Pradesh, India. | India | Antiallergies and medicines used in anaphylaxis | BHU-DRA/B05079 | 10-Mar-20 | 10-Mar-2023 | |
22 | 21 | Essential Medicine | B | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ceftriaxone Sodium (sterile) USP eq. To Ceftriaxone Anhydrous...1000mg | VELXONE-1 Injection | powder for injection with Diluent | 1 gm | Vial and ampoule(diluent) | Each vial contains: Ceftriaxone Sodium (sterile) USP eq. To Ceftriaxone Anhydrous...1000mg | Vellinton Healthcare, Sirmour, India. | India | Antibacterial | BHU-DRA/B05082 | 10-Mar-20 | 10-Mar-2023 | |
23 | 22 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Calcium lactate I.P...300mg | ORBILACTATE 300 Tablet | Tablet | 100 Tablets | HDPE Jar | Each uncoated tablet contains: Calcium lactate I.P...300mg | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Vitamins and minerals | BHU-DRA/ER/B05071 | 10-Mar-20 | 10-Mar-2023 | |
24 | 23 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Beclomethasone Dipropionate I.P 0.025%w/w, Phenylephrine Hydrochloride I.P 0.1%w/w, Lignocaine Hydrochloride I.P 2.50%w/w, Chlorocresol I.P 0.1%w/w | ANORBIT Ointment | Ointment | 15 gm | Collapsible Lami tube | Composition: Beclomethasone Dipropionate I.P 0.025%w/w, Phenylephrine Hydrochloride I.P 0.1%w/w, Lignocaine Hydrochloride I.P 2.50%w/w, Chlorocresol I.P 0.1%w/w | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Steroidal Anti-inflammatory | BHU-DRA/ER/B05070 | 10-Mar-20 | 10-Mar-2023 | |
25 | 24 | Essential Medicine | B | Full Registration | Generic Drug Application | Paruna Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Allopurinol I.P...100mg, Excipients...q.s | ZYLOTIS-100 Tablets | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each uncoated tablet contains: Allopurinol I.P...100mg, Excipients...q.s | SCOTT-EDIL PHARMACIA, Himachal Pradesh, India. | India | Antigout | BHU-DRA/B05080 | 10-Mar-20 | 10-Mar-2023 | |
26 | 25 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Acyclovir I.P...400 mg | OROVIR 400 Tablet | Tablet | 100 Tablets | HDPE Jar | Each uncoated tablet contains: Acyclovir I.P...400 mg | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Antiviral | BHU-DRA/ER/B05072 | 10-Mar-20 | 10-Mar-2023 | |
27 | 26 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Lamgong Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Aciclovir IP…5.0% w/w, In a Cream Base...q.s. | ORCLOVIR Cream | Cream | 5 gm | Collapsible Lami tube | Composition: Aciclovir IP…5.0% w/w, In a Cream Base...q.s. | ORBIT PHARMACEUTICALS., Ahmedabad, India | India | Antiviral | BHU-DRA/ER/B05073 | 10-Mar-20 | 10-Mar-2023 | |
28 | 27 | Non Essential Medicine | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Oxymetazoline Hydrochloride USP...0.25mg in a buffered aqeous solution | Sinarest-PD Nasal Drops | Nasal drops | 10 ml | Lupolene vial | Each ml contains: Oxymetazoline Hydrochloride USP...0.25mg in a buffered aqeous solution | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Nasal Decongestant | BHU-DRA/ER/B05060 | 25-Feb-20 | 24-Feb-2023 | |
29 | 28 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Losartan Potassium IP...25mg | Losatrust 25 Tablet | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Losartan Potassium IP...25mg | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Antihypertensive | BHU-DRA/ER/B05059 | 25-Feb-20 | 24-Feb-2023 | |
30 | 29 | Non Essential Medicine | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Losartan Potassium IP...50mg, Hydrochlorthiazide IP...12.5mg | Losatrust - H Tablet | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Losartan Potassium IP...50mg, Hydrochlorthiazide IP...12.5mg | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Antihypertensive | BHU-DRA/ER/B05058 | 25-Feb-20 | 24-Feb-2023 | |
31 | 30 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Fluconazole BP...150mg | FLUCONAZOLE 150 mg Tablets | Tablet | 3 x 4 Tablets | Alu-Alu Blister | Each tablet contains: Fluconazole BP...150mg | The ACME Laboratories Ltd., Dhaka, Bangladesh. | Bangladesh | Antifungal | BHU-DRA/ER/B05063 | 25-Feb-20 | 24-Feb-2023 | |
32 | 31 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Miconized fenofibrate BP...200mg | LIPIDOF 200 Capsule | Capsule | 2 x 10 Capsules | Alu-PVC Blister | Each capsule contains: Miconized fenofibrate BP...200mg | The ACME Laboratories Ltd., Dhaka, Bangladesh. | Bangladesh | Lipid-lowering agents | BHU-DRA/ER/B05064 | 25-Feb-20 | 24-Feb-2023 | |
33 | 32 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Aspirin BP...75mg | ECOSPRIN 75 Tablets | Tablet | 10 x 10 Tablets | Strip | Each enteric coated tablet contains: Aspirin BP...75mg | The ACME Laboratories Ltd., Dhaka, Bangladesh. | Bangladesh | Antithrombotic | BHU-DRA/ER/B05062 | 25-Feb-20 | 24-Feb-2023 | |
34 | 33 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Magnesium Hydroxide I.P...185mg(added as paste), Simethicone I.P...50mg, Sodium carboxymethylcellulose I.P...100mg, Dried Alumiminium Hydroxide Gel I.P...830mg (addes as paste) | DIGENE (Mint Flavour) | Gel | 200mL | PET Bottle | Each 10mL (two teaspoonfuls approx.) contains: Magnesium Hydroxide I.P...185mg(added as paste), Simethicone I.P...50mg, Sodium carboxymethylcellulose I.P...100mg, Dried Alumiminium Hydroxide Gel I.P...830mg (addes as paste) | Abbott India Limited. | India | Antiulcer | BHU-DRA/ER/B05061 | 25-Feb-20 | 24-Feb-2023 | ||
35 | 34 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Magnesium Hydroxide I.P...185mg (added as paste), Simethicone I.P...50mg, Sodium Carboxymethylcellulose I.P...100mg, Dried Aluminum Hydroxide Gel I.P...830mg (added as paste) | DIGENE® Mixed Fruit Flavour Gel | Gel | 200 ml | PET Bottle | Each 10 ml (2 teaspoonfuls approx.) contains: Magnesium Hydroxide I.P...185mg (added as paste), Simethicone I.P...50mg, Sodium Carboxymethylcellulose I.P...100mg, Dried Aluminum Hydroxide Gel I.P...830mg (added as paste) | Abbott India Limited. | India | Antiulcer | BHU-DRA/ER/B05066 | 25-Feb-20 | 24-Feb-2023 | ||
36 | 35 | B | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Amoxicillin Trihydrate USP eq. To Amoxicillin...500mg, Diluted Potassium Clavulonate BP eq. To Clavulonic Acid...125mg | JOYCLAV-625 Tablet | Tablet | 1 x 10 Tablets | Alu-Alu Blister | Each film coated tablet contains: Amoxicillin Trihydrate USP eq. To Amoxicillin...500mg, Diluted Potassium Clavulonate BP eq. To Clavulonic Acid...125mg | Malik Lifesciences Pvt. Ltd., | India | Antibacterial | BHU-DRA/ER/B05057 | 25-Feb-20 | 24-Feb-2023 | ||
37 | 36 | Essential Medicine | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Acetazolamide BP...250mg | ACEMOX Tablets | Tablet | 10 x 10 Tablets | Strip | Each tablet contains: Acetazolamide BP...250mg | The ACME Laboratories Ltd., Dhaka, Bangladesh. | Bangladesh | Diuretics | BHU-DRA/ER/B05065 | 25-Feb-20 | 24-Feb-2023 | |
38 | 37 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mg | Digene® Orange Flavour Tablet | Tablet | 90 x 15 Tablets | Alu-PVC Blister | Each uncoated chewable tablet contains: Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mg | Abbott India Limited. | India | Antiulcer | BHU-DRA/ER/B05055 | 10-Feb-20 | 9-Feb-2023 | ||
39 | 38 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mg | DIGENE® Mint Flavour Tablet | Tablet | 90 x 15 Tablets | Alu-PVC Blister | Each uncoated chewable tablet contains: Dried Aluminium Hydroxide Gel I.P...300mg, Magnesium Aluminium Silicate Hydrate...50mg, Magnesium Hydroxide I.P...25mg, Simethicone I.P...25mg | Abbott India Limited. | India | Antiulcer | BHU-DRA/ER/B05056 | 10-Feb-20 | 9-Feb-2023 | ||
40 | 39 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ranitidine Hydrochloride USP eq. To Ranitidine...150mg, Excipients...q.s | UMETAC-150 Tablets | Tablet | 10 Strips of 10 Tablets | Strip | Each film coated tablet contains: Ranitidine Hydrochloride USP eq. To Ranitidine...150mg, Excipients...q.s | UMEDICA LABORATORIES Pvt. Ltd. Gujarat, India | India | Antiulcer | BHU-DRA/ER/B05054 | 5-Feb-20 | 4-Feb-2023 | ||
41 | 40 | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | 1 Clarithromycin USP...500mg, 2 Amoxicillin BP...500mg, 1 Rabeprazole Sodium INN...20mg | PYLOCURE® | Tablet and Capsule (combined) | 1 x 7 Blister Strip | Blister strip | Each blister strip contains: 1 Clarithromycin USP...500mg, 2 Amoxicillin BP...500mg, 1 Rabeprazole Sodium INN...20mg | Opsonin Pharma Limited, Barisal, Bangladesh | Bangladesh | Medicines for H.Pylori infection | BHU-DRA/ER/B05053 | 5-Feb-20 | 4-Feb-2023 | ||
42 | 41 | B | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Metformin Hydrochloride BP...500mg, Excipients...q.s | METVIN-500 Tablets | Tablet | 1 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Metformin Hydrochloride BP...500mg, Excipients...q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antidiabetics | BHU-DRA/ER/B05048 | 5-Feb-20 | 4-Feb-2023 | ||
43 | 42 | A1 | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Loperamide Hydrochloride USP...2mg, Excipients...q.s | HOLDAMIDE Tablets | Tablet | 1 x 10 Tablets | Alu-PVC Blister | Each tablet contains: Loperamide Hydrochloride USP...2mg, Excipients...q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antidiarrhoeal | BHU-DRA/ER/B05047 | 5-Feb-20 | 4-Feb-2023 | ||
44 | 43 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Liquid Paraffin I.P...1.25ml, Milk of Magnesia I.P...3.75ml, Sodium Picosulfate B.P...3.33mg | CREMAFFIN® PLUS Refreshing Flavour Oral Emulsion | oral emulsion | 200 ml | PET Bottle | Each 5 mL (1 teaspoon approx.) contains: Liquid Paraffin I.P...1.25ml, Milk of Magnesia I.P...3.75ml, Sodium Picosulfate B.P...3.33mg | Abbott India Limited. | India | Laxatives | BHU-DRA/ER/B05052 | 5-Feb-20 | 4-Feb-2023 | ||
45 | 44 | A1 | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ibuprofen BP...400mg, Excipients...q.s | IBUDEN 400 Tablets | Tablet | 1 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Ibuprofen BP...400mg, Excipients...q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Non-steroidal anti-inflammatory medicines (NSAIMs) | BHU-DRA/ER/B05049 | 5-Feb-20 | 4-Feb-2023 | ||
46 | 45 | B | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ciprofloxacin Hydrochloride USP eq. To Ciprofloxacin...500mg, Excipients...q.s | PROGEN-500 Tablets | Tablet | 1 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Ciprofloxacin Hydrochloride USP eq. To Ciprofloxacin...500mg, Excipients...q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antibacterial | BHU-DRA/ER/B05050 | 5-Feb-20 | 4-Feb-2023 | ||
47 | 46 | B | Expedited Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Atenolol BP...50mg, Excipients...q.s | GENOLOL Tablets | Tablet | 1 x 10 Tablets | Alu-PVC Blister | Each tablet contains: Atenolol BP...50mg, Excipients...q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antianginal | BHU-DRA/ER/B05051 | 5-Feb-20 | 4-Feb-2023 | ||
48 | 47 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Salbutamol Sulphate BP...4.81mg Eq. To Salbutamol...4.0mg, Excipients...q.s | SAMOL-4 Tablet | Tablet | 1000 Tablets | HDPE Jar | Each tablet contains: Salbutamol Sulphate BP...4.81mg Eq. To Salbutamol...4.0mg, Excipients...q.s | WEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIA | India | Antiasthmatic medicines and medicines for chronic obstructive pulmonary disease | BHU-DRA/ER/B05046 | 4-Feb-20 | 3-Feb-2023 | ||
49 | 48 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Risperidone USP...2mg, Excipients...q.s | n/a | Tablet | 100 Tablets (10 x 10) | Alu-Alu Blister | Each uncoated tablet contains: Risperidone USP...2mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antipsychotics | BHU-DRA/ER/B05045 | 4-Feb-20 | 3-Feb-2023 | ||
50 | 49 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Losartan Potassium USP...25mg, Excipients...q.s | LOSA-25 Tablet | Tablet | 1000 Tablets | HDPE Jar | Each tablet contains: Losartan Potassium USP...25mg, Excipients...q.s | WEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIA | India | Antihypertensive | BHU-DRA/ER/B05042 | 4-Feb-20 | 3-Feb-2023 | ||
51 | 50 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ciprofloxacin Hydrochloride USP...582.21mg Eq. To Ciprofloxacin...500mg, Excipients...q.s | CIPFLACIN TABLET | Tablet | 100 Tablets (10 x 10) | Alu-PVC Blister | Each film coated tablet contains: Ciprofloxacin Hydrochloride USP...582.21mg Eq. To Ciprofloxacin...500mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antibacterial | BHU-DRA/ER/B05044 | 4-Feb-20 | 3-Feb-2023 | ||
52 | 51 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | 1.25gm calcium carbonate BP from an organic source (oyster shell) Eq. To elemental calcium ...500mg, Vitamin D3 BP...250 IU, Excipients...q.s | CALVITAN-FORTE Tablet | Tablet | 1000 Tablets | HDPE Jar | Each tablet contains: 1.25gm calcium carbonate BP from an organic source (oyster shell) Eq. To elemental calcium ...500mg, Vitamin D3 BP...250 IU, Excipients...q.s | WEST-COAST PHARMACEUTICAL WORKS LTD, GUJARAT,INDIA | India | Vitamins and minerals | BHU-DRA/ER/B05043 | 4-Feb-20 | 3-Feb-2023 | ||
53 | 52 | B | Full Registration | Generic Drug Application | Dhejung Pharmaceuticals and Medical Supplies | Human Allopathic Medicine | Human Use | Omeprazole I.P (As enteric coated granules)...20mg, Excipients...q.s | OMIDO* Capsules | Capsule | 10 x 10 Capsules | Strip | Each hard gelatin capsule contains: Omeprazole I.P (As enteric coated granules)...20mg, Excipients...q.s | Shine Pharmaceuticals Limited, Ta. Karjan-391 240, Gujarat, India | India | Antiulcer | BHU-DRA/B05040 | 2-Feb-20 | 1-Feb-2023 | ||
54 | 53 | B | Full Registration | Generic Drug Application | Dhejung Pharmaceuticals and Medical Supplies | Human Allopathic Medicine | Human Use | Azithromycin I.P (As dihydrate) equivalent to Azithromycin...500mg, Excipients...q.s | ZOFACIN-500 | Tablet | 10 x 5 Tablets | Alu-PVC Blister | Each film coated tablet contains: Azithromycin I.P (As dihydrate) equivalent to Azithromycin...500mg, Excipients...q.s | Shine Pharmaceuticals Limited, Ta. Karjan-391 240, Gujarat, India | India | Anthelminthics | BHU-DRA/B05041 | 2-Feb-20 | 1-Feb-2023 | ||
55 | 54 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Sterile Water for Injection | SuperAmp | Injectable | 50x5mL | LDPE container | Each 5ml contains: Sterile Water for Injection | Otsuka Pharmaceutical India Private Limited, Ahmedabad, India | India | Diluent | BHU-DRA/ER/B05035 | 31-Jan-20 | 30-Jan-2023 | ||
56 | 55 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Dopamine Hydrochloride I.P...40mg, Water for injections I.P...q.s | DOMIN Injection | Injectable | 5 x 5 Ampoules of 5 ml | Ampoule | Each ml contains: Dopamine Hydrochloride I.P...40mg, Water for injections I.P...q.s | Neon Laboratories Ltd. Mumbai,India | India | Vaccines | BHU-DRA/ER/B05039 | 31-Jan-20 | 30-Jan-2023 | ||
57 | 56 | A1 | Expedited Registration | Generic Drug Application | Human Allopathic Medicine | Human Use | Paracetamol.... BP 500 mg, Caffeine ...USP 65 mg | ATOPEN PLUS Tablet | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each ml contains: Paracetamol.... BP 500 mg, Caffeine ...USP 65 mg | Kemiko Pharmaceuticals Ltd., Bangladesh. | Bangladesh | Non-opioid Analgesics | BHU-DRA/ER/B05038 | 31-Jan-20 | 30-Jan-2023 | |||
58 | 57 | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Paracetamol BP 500 mg & Caffeine BP 65 mg | CAFENOL Tablet | Tablet | 10 x 10 Tablets | Strip | Each film coated tablet contains: Paracetamol BP 500 mg & Caffeine BP 65 mg | General Pharmaceuticals Ltd | Bangladesh | Non-opioid Analgesics | BHU-DRA/ER/B05031 | 31-Jan-20 | 30-Jan-2023 | ||
59 | 58 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Vitamin A 5000 IU Vitamin C 60 mg Vitamin D 400 IU Vitamin E 30 IU Vitamin K 25 mcg Thiamine 1.5 mg Riboflavin 1.7 mg Niacin 20 mg Pyridoxine HCL 2 mg Folic Acid 400 mcg Cyanocobalamin 6 mcg Pantothenic Acid 10 mg Biotin 30 mcg Calcium 162 mg Iron 18 mg Phosphorus 109 mg Iodine 150 mcg Magnesium 100 mg Zinc 15 mg Selenium 20 mcg Copper 2 mg Manganese 2 mg Chromium 120 mcg Molybdenum 75 mcg Chloride 72 mg Potassium 60 mg Boron 150 mcg Nickel 5 mcg Silicon 2 mg Tin 10 mcg Vanadium 10 mcg Lutein 250 mcg | Super Gold Tablet | Tablet | 30 Tablets | HDPE Bottle | Each film coated tablet contains: Vitamin A 5000 IU Vitamin C 60 mg Vitamin D 400 IU Vitamin E 30 IU Vitamin K 25 mcg Thiamine 1.5 mg Riboflavin 1.7 mg Niacin 20 mg Pyridoxine HCL 2 mg Folic Acid 400 mcg Cyanocobalamin 6 mcg Pantothenic Acid 10 mg Biotin 30 mcg Calcium 162 mg Iron 18 mg Phosphorus 109 mg Iodine 150 mcg Magnesium 100 mg Zinc 15 mg Selenium 20 mcg Copper 2 mg Manganese 2 mg Chromium 120 mcg Molybdenum 75 mcg Chloride 72 mg Potassium 60 mg Boron 150 mcg Nickel 5 mcg Silicon 2 mg Tin 10 mcg Vanadium 10 mcg Lutein 250 mcg | General Pharmaceuticals Ltd | Bangladesh | Vitamins and minerals | BHU-DRA/ER/B05030 | 31-Jan-20 | 30-Jan-2023 | ||
60 | 59 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Carvedilol USP…12.5mg, Excipients…q.s | N/A | Tablet | 1000 tablets | HDPE Bottle | Each uncoated tablet contains: Carvedilol USP…12.5mg, Excipients…q.s | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antihypertensive | BHU-DRA/ER/B05034 | 31-Jan-20 | 30-Jan-2023 | ||
61 | 60 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Amikacin sulphate I.P eq. to Amikacin… 250mg. In 2ml aqeous solution, Sodium citrate I.P…1.25% w/v, Sodium metabisulphate I.P…0.33% w/v, preservatives like Propyl paraben I.P…0.02% w/v and Methyl paraben I.P…0.08% w/v, Water for Injections I.P…q.s | AMIKATIL-250 | Injectable | 10x2 mL | Vial | Each vial contains: Amikacin sulphate I.P eq. to Amikacin… 250mg. In 2ml aqeous solution, Sodium citrate I.P…1.25% w/v, Sodium metabisulphate I.P…0.33% w/v, preservatives like Propyl paraben I.P…0.02% w/v and Methyl paraben I.P…0.08% w/v, Water for Injections I.P…q.s | TABLETS (INDIA) LIMITED, 179, T.H. Road, Chennai - 600 081 | India | Antidiabetics | BHU-DRA/ER/B05033 | 31-Jan-20 | 30-Jan-2023 | ||
62 | 61 | E1 | Renewal Registration | Generic Drug Application | Vetline Pharmaceutical and Medical Supplies | Veterinary Allopathic Medicine | Veterinary Use | Albendazole IP...5% w/w, Excipients...q.s | A-ZOLE | powder | 100 gms | HDPE Container | Composition: Albendazole IP...5% w/w, Excipients...q.s | Grampus Laboratories, Johron, Kalaamb, Sirmour (HP), India | India | Anthelminthics | BHU-DRA/RN/B05036 | 31-Jan-20 | 30-Jan-2023 | ||
63 | 62 | A1 | Expedited Registration | Generic Drug Application | TCC Pharmaceutical & Medical Supplies, Phuentsholing, Bhutan | Human Allopathic Medicine | Human Use | Protein Hydrolysate 20%...1.0gm (Equivalent to total Nitrogen...30.0mg), Vitamin B1 I.P...0.5mg, Vitamin B2 I.P...0.5mg, Vitamin B6 I.P...0.5mg, Vitamin B12 I.P...0.25mcg, D-Panthenol I.P...1.0mg, Iron choline Citrate 66% soln...50mg (Equivalent to iron content 6mg), Magnesium Chloride I.P...10.0mg, Manganese Chloride U.S.P...0.1mg, Niacinamide I.P...8.0mg, Flavoured syrupy Base | VINITON™ Syrup | Syrup | 200 ml | Amber Coloured PET Bottle | Each 15 mL contains: Protein Hydrolysate 20%...1.0gm (Equivalent to total Nitrogen...30.0mg), Vitamin B1 I.P...0.5mg, Vitamin B2 I.P...0.5mg, Vitamin B6 I.P...0.5mg, Vitamin B12 I.P...0.25mcg, D-Panthenol I.P...1.0mg, Iron choline Citrate 66% soln...50mg (Equivalent to iron content 6mg), Magnesium Chloride I.P...10.0mg, Manganese Chloride U.S.P...0.1mg, Niacinamide I.P...8.0mg, Flavoured syrupy Base | Mars Remedies Pvt. 635, G.I.D.C. Estate, Waghodia-391760, Dist.:Baroda (Gujarat) | India | Vitamins and minerals | BHU-DRA/ER/B05021 | 30-Dec-19 | 29-Dec-2022 | ||
64 | 63 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Spironolactone B.P...25mg | n/a | Tablet | 1000 tablets | HDPE Jar | Each uncoated tablet contains: Spironolactone B.P...25mg | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Diuretics | BHU-DRA/ER/B05023 | 30-Dec-19 | 29-Dec-2022 | ||
65 | 64 | A1 | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Streptococcus faecalis T-110 JPC...60 Million, Clostridium butyricum TO-A...4 Million, Bacillus mesentericus TO-A JPC...2 Million, Lactic acid bacillus(Lactobacillus Sporogenes)...100 Million, | BIFILAC hp Capsule | Capsule | 10 x 10 Capsules | Alu-Alu Blister | Each capsule contains: Streptococcus faecalis T-110 JPC...60 Million, Clostridium butyricum TO-A...4 Million, Bacillus mesentericus TO-A JPC...2 Million, Lactic acid bacillus(Lactobacillus Sporogenes)...100 Million, | TABLETS (INDIA) LIMITED, 179, T.H. Road, Chennai - 600 081 | India | Antidiabetics | BHU-DRA/ER/B05029 | 30-Dec-19 | 29-Dec-2022 | ||
66 | 65 | A1 | Expedited Registration | Generic Drug Application | TCC Pharmaceutical & Medical Supplies, Phuentsholing, Bhutan | Human Allopathic Medicine | Human Use | Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.S | GUMEX. | Oral Solution | 60 ml | PET Bottle | Composition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.S | Pharmadent Remedies Pvt. Ltd. | India | Antiseptics | BHU-DRA/ER/B05020 | 30-Dec-19 | 29-Dec-2022 | ||
67 | 66 | A1 | Expedited Registration | Generic Drug Application | TCC Pharmaceutical & Medical Supplies, Phuentsholing, Bhutan | Human Allopathic Medicine | Human Use | Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.S | GUMEX. | Oral Solution | 25 ml | PET Bottle | Composition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerin IP...Q.S | Pharmadent Remedies Pvt. Ltd. | India | Antiseptics | BHU-DRA/ER/B05019 | 30-Dec-19 | 29-Dec-2022 | ||
68 | 67 | A1 | Expedited Registration | Generic Drug Application | TCC Pharmaceutical & Medical Supplies, Phuentsholing, Bhutan | Human Allopathic Medicine | Human Use | Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerine IP ..Q.S | GUMEX. | Oral Solution | 10 ml | PET Bottle | Composition: Potassium Iodide IP 0.8%w/v, Iodine IP 0.6% w/v, Tannic acid USP 2.0% w/v, Menthol IP 0.5% w/v, Thymol IP 0.5% w/v, Camphor USP 0.5% w/v, Zinc phenol sulphonate 0.8% w/v, Mentha Oil IP 0.3% v/v, Clove Oil IP 0.3% v/v, Phenol 0.2% IP w/v, Glycerine IP ..Q.S | Pharmadent Remedies Pvt. Ltd. | India | Antiseptics | BHU-DRA/ER/B05018 | 30-Dec-19 | 29-Dec-2022 | ||
69 | 68 | A1 | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Lactulose Concentrate U.S.P equivalent to Lactulose...10g, Aqeous flavored base...q.s | Cadilose Solution | Solution | 100 ml | Amber Coloured PET Bottle | Each 15mL contains: Lactulose Concentrate U.S.P equivalent to Lactulose...10g, Aqeous flavored base...q.s | CADILA PHARMACEUTICALS LIMITED, Ahmedabad, India. | India | Laxatives | BHU-DRA/ER/B05026 | 30-Dec-19 | 29-Dec-2022 | ||
70 | 69 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | FluoxetineHydrochloride I.P equivalent to Fluoxetine...20mg | Fludac 20 mg Capsule | Capsule | 10 x 2 x 15 Capsules | Alu-PVC Blister | Each hard gelatin capsule contains: FluoxetineHydrochloride I.P equivalent to Fluoxetine...20mg | CADILA PHARMACEUTICALS LIMITED, Ahmedabad, India. | India | Antidepressant | BHU-DRA/ER/B05027 | 30-Dec-19 | 29-Dec-2022 | ||
71 | 70 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Carbamazepine U.S.P...200mg | n/a | Tablet | 1000 tablets | HDPE Jar | Each tablet contains: Carbamazepine U.S.P...200mg | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Anticonvulsant/ Antiepileptics | BHU-DRA/ER/B05024 | 30-Dec-19 | 29-Dec-2022 | ||
72 | 71 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Atorvastatin Calcium I.P equivalent to Atorvastatin | ATORBEST 10 Tablet | Tablet | 5 x 3 x 10 Tablets | Alu-Alu Blister | Each film coated tablet contains: Atorvastatin Calcium I.P equivalent to Atorvastatin | CADILA PHARMACEUTICALS LIMITED, Ahmedabad, India. | India | Lipid-lowering agents | BHU-DRA/ER/B05028 | 30-Dec-19 | 29-Dec-2022 | ||
73 | 72 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Amlodipine Besylate equivalent to Amlodipine U.S.P...5 mg | n/a | Tablet | 1000 tablets | HDPE Jar | Each tablet contains: Amlodipine Besylate equivalent to Amlodipine U.S.P...5 mg | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antihypertensive | BHU-DRA/ER/B05025 | 30-Dec-19 | 29-Dec-2022 | ||
74 | 73 | B | Expedited Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Amitriptyline Hydrochloride B.P...25mg | n/a | Tablet | 1000 tablets | HDPE Jar | Each film coated tablet contains: Amitriptyline Hydrochloride B.P...25mg | Holden Medical Laboratories Pvt. Ltd. Nashik-422 113, India | India | Antidepressant | BHU-DRA/ER/B05022 | 30-Dec-19 | 29-Dec-2022 | ||
75 | 74 | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Phenoxymethylpenicillin Potassium BP...277.2mg equivalent to Phenoxymethylpenicillin...250mg | OPEN 250 Tablet | Tablet | 10 x 10 Tablets | Strip | Each tablet contains: Phenoxymethylpenicillin Potassium BP...277.2mg equivalent to Phenoxymethylpenicillin...250mg | Opsonin Pharma Limited, Barisal, Bangladesh | Bangladesh | Antibacterial | BHU-DRA/ER/B05017 | 16-Dec-19 | 15-Dec-2022 | ||
76 | 75 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | zinc sulfate monohydrate USP equivalent to elemental zinc...20mg | Xinc 20 Tablet | Tablet | 60 Tablets | Alu-PVDC Blister | Each tablet contains: zinc sulfate monohydrate USP equivalent to elemental zinc...20mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Vitamins and minerals | BHU-DRA/ER/B05015 | 10-Dec-19 | 9-Dec-2022 | ||
77 | 76 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Nitrofurantoin BP...100mg, Excipients...q.s | NYTODEV Tablets | Tablet | 10 x 10 | Alu-PVC Blister | Each uncoated tablet contains: Nitrofurantoin BP...100mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antibacterial | BHU-DRA/ER/B05016 | 10-Dec-19 | 9-Dec-2022 | ||
78 | 77 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Prednisolone BP...20mg | PRED 20 Tablet | Tablet | 50 Tablets | Alu-PVDC Blister | Each tablet contains: Prednisolone BP...20mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Steroidal Anti-inflammatory | BHU-DRA/ER/B05014 | 6-Dec-19 | 5-Dec-2022 | ||
79 | 78 | E2 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Veterinary Allopathic Medicine | Veterinary Use | Flunixin Meglumine USP equivalent to Flunixin...50mg | Pif R vet Injection | Injectable | 10 ml | Vial | Each ml contains: Flunixin Meglumine USP equivalent to Flunixin...50mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Non-steroidal anti-inflammatory medicines (NSAIMs) | BHU-DRA/ER/B05013 | 6-Dec-19 | 5-Dec-2022 | ||
80 | 79 | B | Full Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | D-Panthenol I.P...5.0%w/v, Sodium Hyaluronate B.P Eq. To Hyaluronic Acid...0.1% w/v, Stabilized Oxychloro Complex...0.01% w/v (As Preservative), Sterile Aqeous Vehicle...Q.S | OPTIVIEW -HA Eye Drops | Drops | 10 ml | Lupolene Bottle | Composition: D-Panthenol I.P...5.0%w/v, Sodium Hyaluronate B.P Eq. To Hyaluronic Acid...0.1% w/v, Stabilized Oxychloro Complex...0.01% w/v (As Preservative), Sterile Aqeous Vehicle...Q.S | Suyaash Pharmaceuticals, 216/5-6, Village Khundh, Taluka-Chikhli, Dist-Navsari-396521, Gujarat. | India | Opthalmic lubricant | BHU-DRA/B05013 | 4-Dec-19 | 3-Dec-2022 | ||
81 | 80 | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Silymarin...70mg, Thiamine monohydrate IP...5mg, Riboflavin IP...5mg, Pyridoxine Hydrochloride IP...1.5mg, Niacinamide IP...25mg, Calcium Pantothenate IP...7.5mg, Vitamin B12 IP...5mcg, Excipients...q.s | LIVOSIL-B Capsule | Capsule | 10 Blisters of 10 Capsules each | Blister | Each capsule contains: Silymarin...70mg, Thiamine monohydrate IP...5mg, Riboflavin IP...5mg, Pyridoxine Hydrochloride IP...1.5mg, Niacinamide IP...25mg, Calcium Pantothenate IP...7.5mg, Vitamin B12 IP...5mcg, Excipients...q.s | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Vitamins and minerals | BHU-DRA/ER/B05007 | 3-Dec-19 | 2-Dec-2022 | ||
82 | 81 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Losartan Potassium IP...50mg, | Losatrust 50 Tablets | Tablet | 10 x 10 Tablets | Blister | Each film coated tablet contains: Losartan Potassium IP...50mg, | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Antihypertensive | BHU-DRA/ER/B05006 | 3-Dec-19 | 2-Dec-2022 | ||
83 | 82 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ketaconazole IP...2% w/v, Lotion Base...q.s, Preservative: Imidazolidinyl Urea...0.3%w/v | Kz Lotion | lotion | 50 ml | Collapsible Lami Tube | Composition: Ketaconazole IP...2% w/v, Lotion Base...q.s, Preservative: Imidazolidinyl Urea...0.3%w/v | HeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.) | India | Antifungal | BHU-DRA/ER/B05008 | 3-Dec-19 | 2-Dec-2022 | ||
84 | 83 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Griseofulvin BP...250mg, Excipients...q.s | DEVOGRI Tablets | Tablet | 10 x 10 Tablets | Blister | Each uncoated tablet contains: Griseofulvin BP...250mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antifungal | BHU-DRA/ER/B05005 | 3-Dec-19 | 2-Dec-2022 | ||
85 | 84 | A2 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Aloe vera Gel...10% w/w, Light Liquid Paraffin...10%w/w, Calamine...8%w/w, In a moisturising lotion base containing Dimethicone and Olivem-800 | n/a | lotion | 100 ml | Lami Collapsible tube | Composition: Aloe vera Gel...10% w/w, Light Liquid Paraffin...10%w/w, Calamine...8%w/w, In a moisturising lotion base containing Dimethicone and Olivem-800 | HeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.) | India | Anti-inflammatory and antipruritic | BHU-DRA/ER/B05010 | 3-Dec-19 | 2-Dec-2022 | ||
86 | 85 | A2 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Aloe Vera Gel...10% w/w, Light liquid paraffin...10% w/w, Calamine...8% w/w, In a moisturising lotion base containing Dimethicone and Olivem-800 | n/a | lotion | 60 ml | Lami Collapsible tube | Composition: Aloe Vera Gel...10% w/w, Light liquid paraffin...10% w/w, Calamine...8% w/w, In a moisturising lotion base containing Dimethicone and Olivem-800 | HeSa Pharmaceutica, Batoli Kalan, Baddi, Dist.: 173 205 (H.P.) | India | Anti-inflammatory and antipruritic | BHU-DRA/ER/B05009 | 3-Dec-19 | 2-Dec-2022 | ||
87 | 86 | A1 | Full Registration | Generic Drug Application | Kuenphen Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Sodium Carboxymethyl cellulose IP...0.5%w/v, Stabilized Oxychloro complex...0.005% w/v (As preservative), Purified water IP...Q.S | OPTIVIEW Lubricant Eye Drops | Drops | 10 ml | Lupolene Bottle | Composition: Sodium Carboxymethyl cellulose IP...0.5%w/v, Stabilized Oxychloro complex...0.005% w/v (As preservative), Purified water IP...Q.S | Suyaash Pharmaceuticals, 216/5-6, Village Khundh, Taluka-Chikhli, Dist-Navsari-396521, Gujarat. | India | Opthalmic lubricant | BHU-DRA/B05012 | 3-Dec-19 | 2-Dec-2022 | ||
88 | 87 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Norfloxacin BP...400mg, Excipients...q.s | NORDEV Tablets | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Norfloxacin BP...400mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antibacterial | BHU-DRA/ER/B05004 | 27-Nov-19 | 26-Nov-2022 | ||
89 | 88 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Tolfenamic Acid BP...200mg | Tufnil Tablet | Tablet | 50 Tablets | Alu-PVC Blister | Each tablet contains: Tolfenamic Acid BP...200mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Non-steroidal anti-inflammatory medicines (NSAIMs) | BHU-DRA/ER/B05003 | 26-Nov-19 | 25-Nov-2022 | ||
90 | 89 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Clopidogrel Bisulfate USP eq. To Clopidogrel...75 mg, Excipients...q.s | DEVIGREL 75 Tablets | Tablet | 10 x 10 Tablets | Alu-PVC Blister | Each film coated tablet contains: Clopidogrel Bisulfate USP eq. To Clopidogrel...75 mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antithrombotic | BHU-DRA/ER/B05002 | 26-Nov-19 | 25-Nov-2022 | ||
91 | 90 | B | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Itopride Hydrochloride...50mg, Excipients...q.s | Ganaton® Tablet | Tablet | 10 x 10 Tablets | Blister | Each film coated tablet contains: Itopride Hydrochloride...50mg, Excipients...q.s | Abbott India Limited. | India | Prokinetic | BHU-DRA/ER/B05001 | 21-Nov-19 | 20-Nov-2022 | ||
92 | 91 | A1 | Expedited Registration | Generic Drug Application | Zamling Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ibuprofen I.P...400mg | BRUFEN 400 | Tablet | 15x4x15 Tablets | Blister | Each film coated tablet contains: Ibuprofen I.P...400mg | Abbott India Limited. | India | Non-steroidal anti-inflammatory medicines (NSAIMs) | BHU-DRA/ER/B05000 | 21-Nov-19 | 20-Nov-2022 | ||
93 | 92 | F | Abridged Registration | Generic Drug Application | Department of Public Health, Ministry of Health, Bhutan | Human Allopathic Medicine | Human Use | Active ingredient: Purified inactivated influenza Virus Antigen (In-House) A strain (2019-20 NH Formula) A Brisbance/02/2018 Reassortant virus IVR-190(H1N1)...15microgram, [A/Kansas/14/2017 Reassortant virus NYMC X-327 (H3N2)...15microgram, B Strain (2019-20 NH Formula) [B/Maryland/15/2016 Reassortant virus NYMC BX-69(BV)...15 microgram, Buffer sodium chloride(USP)...4.25mg, Di-Sodium hydrogen phosphate dodecahydrate (EP)...1.40mg, Potassium dihydrogen phosphate (EP)...0.15 mg, Solvent: Water for injection (KP)...q.s | IL-Yang Flu Vaccine Prefilled Syringe Injection | Injectable | 0.5 ml | Vial | 1 vial (0.5mL) contains: Active ingredient: Purified inactivated influenza Virus Antigen (In-House) A strain (2019-20 NH Formula) A Brisbance/02/2018 Reassortant virus IVR-190(H1N1)...15microgram, [A/Kansas/14/2017 Reassortant virus NYMC X-327 (H3N2)...15microgram, B Strain (2019-20 NH Formula) [B/Maryland/15/2016 Reassortant virus NYMC BX-69(BV)...15 microgram, Buffer sodium chloride(USP)...4.25mg, Di-Sodium hydrogen phosphate dodecahydrate (EP)...1.40mg, Potassium dihydrogen phosphate (EP)...0.15 mg, Solvent: Water for injection (KP)...q.s | IL-Yang Pharma. Co., Ltd., | Korea | Vaccines | BHU-DRA/AR/B04982 | 20-Nov-19 | 19-Nov-2022 | ||
94 | 93 | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Oxymetazoline Hydrochloride USP...0.5mg | Sinarest Nasal Drops | Drops | 10 ml | Lupolene Vial | Each ml contains: Oxymetazoline Hydrochloride USP...0.5mg | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Nasal Decongestant | BHU-DRA/ER/B04997 | 20-Nov-19 | 19-Nov-2022 | ||
95 | 94 | B | Full Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Ondansetron Hydrochloride USP equivalent to Ondansetron...4mg, Sodium Chloride USP...18mg, Citric Acid Monohydrate USP...1mg, Sodium Citrate USP...0.5mg, Water for Injection USP...q.s | ONSTAR 4 Injection | Injectable | 10 Ampoules of 2 ml each | Ampoule | Each sterile ampoule contains: Ondansetron Hydrochloride USP equivalent to Ondansetron...4mg, Sodium Chloride USP...18mg, Citric Acid Monohydrate USP...1mg, Sodium Citrate USP...0.5mg, Water for Injection USP...q.s | Celon Laboratories Pvt. Ltd., Plot No: 2, ALEAP Industrial Estate, Telangana state, India. | India | Antiemetic | BHU-DRA/B04999 | 20-Nov-19 | 19-Nov-2022 | ||
96 | 95 | B | Abridged Registration | Generic Drug Application | Karma Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Soyabean Oil USP...10.00g, Egg Lecithen...1.20g, Glycerol USP...2.25g, Water for injections BP...q.s, Energy Content...1100 kcal/L, Osmolarity...300 mOsmol/L | CELEPID 10% Intravenous Fat Emulsion | Injectable | 500 ml | Glass Bottle | Each 100ml (of emulsion) contains: Soyabean Oil USP...10.00g, Egg Lecithen...1.20g, Glycerol USP...2.25g, Water for injections BP...q.s, Energy Content...1100 kcal/L, Osmolarity...300 mOsmol/L | Otsuka Pharmaceutical India Private Limited, Ahmedabad, India | India | Lipid emulsion for parenteral nutrition | BHU-DRA/AR/B04983 | 20-Nov-19 | 19-Nov-2022 | ||
97 | 96 | B | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Polymyxin-B Sulphate BP...10000 Units, Chloramphenicol IP...10mg, Sterile base...q.s | OCUPOL Eye Ointment | Ointment | 5 g | Collapsible tube | Each gm contains: Polymyxin-B Sulphate BP...10000 Units, Chloramphenicol IP...10mg, Sterile base...q.s | Centaur Pharmaceuticals Pvt. Ltd., Santacruz(E0,Mumbai 400 055 India | India | Antibacterial | BHU-DRA/ER/B04986 | 20-Nov-19 | 19-Nov-2022 | ||
98 | 97 | A1 | Expedited Registration | Generic Drug Application | Namsey Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Bromhexine Hydrochloride BP...4 mg | Mucoten Syrup | Syrup | 100 ml | PET Bottle | Each 5 ml of syrup contains: Bromhexine Hydrochloride BP...4 mg | ESKAYEF BANGLADESH LIMITED | Bangladesh | Mucoactive agent | BHU-DRA/ER/B04998 | 20-Nov-19 | 19-Nov-2022 | ||
99 | 98 | B | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Warfarin Sodium BP...1mg, Excipients...q.s | REFARIN TM | Tablet | 10 x 10 | Alu-PVC Blister | Each uncoated tablet contains: Warfarin Sodium BP...1mg, Excipients...q.s | Dev Life Corporation, Himatnagar-383 001, Gujarat, India | India | Antithrombotic | BHU-DRA/ER/B04993 | 12-Nov-19 | 11-Nov-2022 | ||
100 | 99 | C1 | Expedited Registration | Generic Drug Application | Tsampaka Pharmaceutical and Medical Supplies | Human Allopathic Medicine | Human Use | Tramadol Hydrochloride I.P...50mg, Water for injections I.P...q.s | SUPRIDOL Injection | Injectable | 10 x 5 Amps. Of 1 ml | Ampoule | Each ml contains: Tramadol Hydrochloride I.P...50mg, Water for injections I.P...q.s | Neon Laboratories Ltd. Mumbai,India | India | Opioid analgesics | BHU-DRA/ER/B04983 | 12-Nov-19 | 11-Nov-2022 |