| View |
DR-XY48586_PI_01.pdf
|
DR-XY48586
|
Lurasidone Hydrochloride
|
Latuda
|
80 mg
|
Film-Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13378
|
Clindamycin (as hydrochloride)
|
Clintop
|
300 mg
|
Capsule
|
-
|
Fredun Pharmaceutical Limited
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13389
|
Teicoplanin
|
Teicopix
|
200 mg
|
Lyophilized Powder for solution for Injection/Infusion
|
-
|
Lek Pharmaceuticals d.d.
|
Slovenia
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13390
|
Teicoplanin
|
Teicopix
|
400 mg
|
Lyophilized Powder for solution for Injection/Infusion
|
-
|
Lek Pharmaceuticals d.d.
|
Slovenia
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13380
|
Simvastatin
|
Simvasyn
|
20mg
|
Film-Coated Tablets
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13270
|
Atorvastatin (as calcium)
|
Khrizstatin 40
|
40 mg
|
Film-Coated Tablet
|
-
|
Ceclogen Generics Private Ltd.
|
India
|
Initial [Re-application]
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13385
|
Amlodipine (as besilate) + Bisoprolol fumarate
|
Unbranded
|
5 mg/5mg
|
Film-Coated Tablet
|
Calcium Channel Blocker/Beta Blocking Agent
|
Novagen Healthcare Private Limited
|
India
|
Renewal
|
21 October 2024
|
10 February 2030
|
| View |
|
DRP-13383
|
Amlodipine (as besilate) + Atorvastatin (as calcium)
|
None
|
10 mg/10 mg
|
Film-Coated Tablet
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
10 February 2023
|
10 February 2025
|
| View |
|
DR-XY48615
|
Rosuvastatin (as calcium)
|
Chaletin
|
5 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48616
|
Rosuvastatin (as calcium)
|
Chaletin
|
10 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
DRP-13372_PI_01.pdf
|
DRP-13372
|
Nitroglycerin
|
Glisenit
|
1 mg/mL
|
Solution For Injection (IV Infusion)
|
-
|
Rompharm İlaç San. Ve Tic. Ltd. Şti.
|
Turkey
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13374
|
Moxifloxacin (as Hydrochloride)
|
Plaxomib
|
5 mg/mL (0.5% 0.5% w/v)
|
Ophthalmic Solution
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DRP-13395
|
Metronidazole (as benzoate)
|
Trinosaph
|
10 mg/g (1 % w/w)
|
Topical Gel
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48618
|
Rosuvastatin (as calcium)
|
Chaletin
|
40 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48617
|
Rosuvastatin (as calcium)
|
Chaletin
|
20 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DRP-13384
|
Amlodipine (as besilale) + Bisoprolol fumarate
|
Ambisopro
|
5 mg/5mg
|
Film-Coated Tablet
|
Calcium Channel Blocker/Beta Blocking Agent
|
Novagen Healthcare Private Limited
|
India
|
Renewal
|
12 October 2024
|
10 February 2030
|
| View |
|
DRP-13373
|
Rivaroxaban
|
Novarox-20
|
20mg
|
Film-Coated Tablet
|
-
|
Titan Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48610
|
Letrozole
|
Letrosaph
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48607
|
Rivaroxaban
|
Xarelto
|
20 mg
|
Film-Coated Tablet
|
-
|
Bayer Bitterfeld GmbH
|
Germany
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48608
|
Rivaroxaban
|
Xarelto
|
15 mg
|
Film-Coated Tablet
|
-
|
Bayer Bitterfeld GmbH
|
Germany
|
Initial
|
08 February 2023
|
08 February 2028
|