| View |
|
DRP-11040-01
|
Telmisartan
|
Misartan 80
|
80 mg
|
Tablet
|
Angiotensin Ii Receptor Blocker
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (CLIDP)
|
02 August 2022
|
12 January 2027
|
| View |
|
DRP-11041-01
|
Telmisartan
|
Misartan 40
|
40 mg
|
Tablet
|
Angiotensin II Receptor Blocker
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (CLIDP)
|
02 August 2022
|
12 January 2027
|
| View |
|
DRP-12414
|
Pregabalin
|
Gabasyn
|
150 mg
|
Capsule
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12413
|
Pregabalin
|
Gabasyn
|
50 mg
|
Capsule
|
Antiepileptic
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
DR-XY48236_PI_01.pdf
|
DR-XY48236
|
Capmatinib (As Hydrochloride)
|
Rahika
|
150 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma produktions GmbH
|
Germany
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
DR-XY48237_PI_01.pdf
|
DR-XY48237
|
Capmatinib (As Hydrochloride)
|
Rahika
|
200 mg
|
Film-Coated Tablet
|
-
|
Novartis Pharma produktions GmbH
|
Germany
|
Monitored Release
|
29 July 2022
|
29 July 2027
|
| View |
|
DRP-12450
|
Losartan (as potassium) + Hydrochlorothiazide
|
Lorzide
|
50mg/12.5mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Antagonist / Diuretic
|
Acme Formulation Pvt., Ltd.
|
India
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
DRP-12411_PI_01.pdf
|
DRP-12411
|
Sevelamer carbonate
|
None
|
800 mg
|
Film-Coated Tablet
|
Phosphate Binder
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DRP-12423
|
Anagrelide (as hydrochloride)
|
None
|
500 mcg
|
Tablet
|
Antineoplastic Agent
|
Indeus Life Sciences Pvt. Ltd
|
India
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12421
|
Pregabalin
|
None
|
75 mg
|
capsule
|
Antiepileptic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DRP-12420
|
Pregabalin
|
None
|
50 mg
|
capsule
|
Antiepileptic
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
08 August 2022
|
08 August 2027
|
| View |
|
DR-XY37906
|
Dapoxetine (as hydrochloride)
|
Priligy
|
30mg
|
Film-Coated Tablet
|
-
|
Menarini -Von Heyden GmbH
|
Germany
|
Initial
|
10 August 2022
|
01 April 2026
|
| View |
|
DR-XY37907
|
Dapoxetine (as hydrochloride)
|
Priligy
|
60 mg
|
Film-Coated Tablet
|
-
|
Menarini -Von Heyden GmbH
|
Germany
|
Initial
|
10 August 2022
|
01 April 2026
|
| View |
|
DRP-12456
|
Vancomycin (as Hydrochloride)
|
Philvan
|
1 g
|
Lyophilized Powder for IV Infusion
|
Antibacterial (Glycopeptide)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48269
|
Ropinirole (as hydrochloride)
|
Kinetica
|
4 mg
|
Prolonged Release Tablet
|
Anti-Parkinson Drug (Dopamine Agonist)
|
KRKA, d.d., Novo Mesto
|
Slovenia
|
Initial
|
10 August 2022
|
10 August 2027
|
| View |
|
DR-XY48188
|
Peritoneal Dialysis Solution with 4.25% Dextrose
|
CAPD/DPCA 18 Stay Safe Link Solution for Peritoneal
Dialysis
|
46.7g/183.8mg/101.7mg/3.925g/5.786g
|
Solution for Peritoneal
Dialysis
|
-
|
Fresenius Medical Care Production Sdn. Bhd.
|
Malaysia
|
Initial (Variation)
|
14 August 2023
|
14 August 2028
|
| View |
|
DR-XY48259
|
Safinamide (as mesilate)
|
Equfina
|
50mg
|
Film-Coated Tablet
|
-
|
Meiji Seika Pharma Co., Ltd. (Odawara Plant)
|
Japan
|
Monitored Release
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12424
|
Omeprazole (as sodium monohydrate)
|
Aciflux
|
40mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 August 2022
|
04 August 2027
|
| View |
|
DRP-12415
|
Citicoline (as sodium)
|
Colitab
|
1 g
|
Film-Coated Tablet
|
Psychostimulant and Nootropic
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
03 August 2022
|
03 August 2027
|
| View |
|
DR-XY48260
|
Rizatriptan
|
Migratan
|
10 mg
|
Tablet
|
Antimigraine (Selective serotonin (5HT1) agonist]
|
Cadila Healthcare Limited
|
India
|
Monitored Release
|
05 August 2022
|
05 August 2025
|