| View |
|
DRP-4161-03
|
Trimetazidine Dihydrochloride
|
Cardiotaz 20
|
20 mg
|
Film-Coated Tablet
|
Fatty Acid Oxidation (pFOX) Inhibitor
|
Maple Pharmaceuticals (Pvt.) Limited
|
Pakistan
|
Renewal
|
16 August 2022
|
26 December 2027
|
| View |
|
DRP-5195-07
|
Paracetamol + Tramadol Hydrochloride
|
Unbranded
|
325 mg/37.5 mg
|
Film-Coated Tablet
|
Analgesic
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Renewal
|
16 August 2022
|
03 March 2028
|
| View |
|
DRP-6895-01
|
PANTOPRAZOLE (AS SODIUM SESQUIHYDRATE)
|
BRILIPAN-40
|
40 MG
|
ENTERIC COATED TABLET
|
Proton Pump Inhibitor
|
HETERO LABS LIMITED (UNIT V)
|
India
|
Renewal
|
16 August 2022
|
05 June 2027
|
| View |
|
DR-XY38790
|
Omeprazole Sodium
|
Ulcomez
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Naprod Life Sciences Pvt. Ltd.
|
India
|
Renewal
|
18 August 2022
|
30 November 2027
|
| View |
DRP-11535_PI_01.pdf
|
DRP-11535
|
Linagliptin
|
Trajenta
|
5mg
|
Tablet
|
Blood Glucose Lowering Drugs
|
West-Ward Columbus, Inc.
|
United States of America
|
Monitored Release
|
24 March 2022
|
28 February 2025
|
| View |
|
DRP-11526
|
Salbutamol
|
Docsal
|
2 mg
|
Tablet
|
Bronchodilator
|
Phil. United Pharma Corporation (PUPC)
|
Philippines
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11527
|
Salbutamol (As Sulfate)
|
Gomol
|
2 mg
|
Tablet
|
Selective Beta-2-Adrenoreceptor Agonist
|
Phil. United Pharma Corporation (PUPC)
|
Philippines
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11528
|
Carboplatin
|
Carbofon
|
10 mg/mL (450 mg/45mL)
|
Concentrate Solution for
Infusion (IV)
|
Antineoplastic Agent
|
PT Fonko International Pharmaceuticals
|
Indonesia
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47027
|
Cetrorelix (as acetate)
|
Cetrolix
|
250 mcg
|
Lyophilized Powder For Injection (SC)
|
-
|
Gufic Biosciences Limited.
|
India
|
Initial
|
28 August 2020
|
28 August 2025
|
| View |
|
DRP-12382
|
Sodium Bicarbonate
|
Armacarbo
|
84 mg/mL (8.4% w/v)
|
Solution for Injection (I.V.)
|
Electrolyte Solutions
|
Jeil Pharmaceutical Co., Ltd.
|
Korea
|
Automatic Renewal
|
29 July 2022
|
29 July 2027
|
| View |
|
DR-XY48253
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
None
|
Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
538 mg 448 mg 25.7 mg 5.08 mg
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DR-XY48252
|
Peritoneal Dialysis Solution with 2.5% Dextrose
|
None
|
Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
538 mg 448 mg 25.7 mg 5.08 mg
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DR-XY48251
|
Peritoneal Dialysis Solution with 1.5% Dextrose
|
None
|
Formulation: Each 100 mL contains:
Dextrose Anhydrous, BP Sodium Chloride, BP Sodium Lactate, BP Calcium Chloride, BP Magnesium Chloride, BP
1.5 g 538 mg 448 mg 25.7 mg 5.08 mg
|
Dialysis Solution
(Intraperitoneal)
|
Peritoneal Dialytic
|
Mitra Industries (P) Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DRP-12416
|
0.9% Sodium Chloride
|
0.9% NaCl-Sapher
|
9 mg/mL (0.9% w/v)
|
Solution For Injection
|
Electrolyte Solution
|
Althea Pharma Pvt. Ltd.
|
India
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12387
|
Ketoconazole
|
Ketocorex
|
20mg/g (2% w/w)
|
Topical Cream
|
Antifungal
|
Next Wave (India)
|
India
|
Initial (OTC)(PCPR)
|
29 July 2022
|
29 July 2027
|
| View |
|
BR-1354
|
Diphtheria-Tetanus Vaccine (Adsorbed, Reduced
Antigen Content)
|
BE Td
|
Each dose (0.5 mL) contains: Diphtheria toxoid- 2 Lf (>2 IU)
Tetanus toxoid- 8.8 Lf (>20 IU) Adsorbed on Aluminum Phosphate-> 1.5 mg Preservative: Thiomersal BP-0.01% w/v
|
Solution For Injection (I.M)
|
Vaccines
|
Biological E. Limited
|
India
|
Initial
|
17 June 2021
|
17 June 2026
|
| View |
|
DRP-12454
|
Vildagliptin
|
Vildasaph -50
|
50mg
|
Tablet
|
Oral Hypoglycemin (Dpp - 4 Inhibitor)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48258
|
Multivitamins + Minerals
|
None
|
500 mg
|
Capsule
|
-
|
Yue-Sheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12453
|
Vitamin B Complex + Iron
|
Ameniofer-B
|
15 mg/10 mg/ 10 mg/10 mcg/91.50 mg/1 mg
|
Film-Coated Tablet
|
Vitamins/Mineral (Hematinic)
|
Ocean Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
11 August 2022
|
11 August 2027
|
| View |
|
DRP-12417
|
Iron (As Ferrous Sulfate Heptahydrate)
|
Fesusaph-30
|
30 mg (equivalent to 150 mg Ferrous Sulfate Heptahydrate)/ 5 mL
|
Syrup (Orange Flavor)
|
Mineral (Anti-Anemia)
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
04 August 2022
|
04 August 2027
|