| View |
|
DRP-11321
|
Ofloxacin
|
Famoxa
|
200mg/100mL
|
Solution For Intravenous Infusion
|
Antibacterial (Quinolone)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47769
|
Rocuronium Bromide
|
Rocum
|
10 mg/mL
|
Solution For Injection (IV)
|
Muscle Relaxant
|
PT Ferron PAR Pharmaceuticals
|
Indonesia
|
Initial
|
04 March 2022
|
04 March 2027
|
| View |
|
DR-XY47774
|
Zonisamide
|
Zoresan®
|
25 mg
|
Capsule
|
Antiepileptic
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
|
DR-XY47773
|
Zonisamide
|
Zoresan®
|
50 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
|
DR-XY47772
|
Zonisamide
|
Zoresan®
|
100 mg
|
Capsule
|
-
|
Kusum Healthcare Pvt. Ltd.
|
India
|
Monitored Release
|
04 March 2022
|
04 March 2027
|
| View |
|
DRP-11315
|
Zoledronic acid (as monohydrate)
|
Zolefon
|
4 mg/5 mL
|
Concentrate Solution for IV Infusion
|
Bisphosphonate
|
Pt. Fonko International Pharmaceuticals
|
Indonesia
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
|
DR-XY47716
|
Vancomycin (as hydrochloride)
|
Vancocyn
|
500 mg
|
Powder for Injection (IV)
|
Antibacterial (Glycopeptide)
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
02 March 2022
|
02 March 2027
|
| View |
|
DR-XY47759
|
Cinnarizine
|
Stugeron
|
25 mg
|
Tablet
|
-
|
Janssen Cilag S.p.A.
|
Italy
|
-
|
28 February 2022
|
28 February 2027
|
| View |
|
DRP-11317
|
Quetiapine (as fumarate)
|
Serotia XR 50
|
50 mg
|
Extended Release Tablet
|
Antipsychotic
|
Pharmathen International SA
|
Greece
|
Initial (Reconstruction)
|
22 May 2024
|
28 February 2027
|
| View |
|
DRP-11316
|
Quetiapine (as fumarate)
|
Serotia XR 400
|
400 mg
|
Extended Release Tablet
|
Antipsychotic
|
Pharmathen International SA
|
Greece
|
Initial (Reconstruction)
|
22 May 2024
|
28 February 2027
|
| View |
|
DRP-11318
|
Quetiapine (as fumarate)
|
Serotia XR 200
|
200 mg
|
Extended-Release Tablet
|
Antipsychotic
|
Pharmathen International SA
|
Greece
|
Initial (Reconstruction)
|
22 May 2024
|
28 February 2027
|
| View |
|
DR-XY47763
|
Rivastigmine
|
Rivazin
|
9 mg/5 cm (4.6 mg/24 hours)
|
Transdermal Patch
|
-
|
Icure Pharmaceutical Inc.
|
Korea
|
-
|
02 March 2022
|
02 March 2027
|
| View |
|
DR-XY47762
|
Rivastigmine
|
Rivazin
|
18 mg/10 cm2 (9.5mg/24 hours)
|
Transdermal Patch
|
-
|
Icure Pharmaceutical Inc.
|
Korea
|
-
|
02 March 2022
|
02 March 2027
|
| View |
|
DR-XY47751
|
Estradiol valerate
|
Progynova
|
2 mg
|
Sugar-Coated Tablet
|
Estrogen
|
Bayer Weimar Gmbh Und Co. Kg
|
Germany
|
Initial
|
28 February 2022
|
28 February 2027
|
| View |
DR-XY47770_PI_01.pdf
|
DR-XY47770
|
Macitentan
|
Opsumit
|
10 mg
|
Film-Coated Tablet
|
Antihypertensive
|
Excella GmbH & Co. KG
|
Germany
|
Monitored Release
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-11342
|
Ondansetron (as hydrochloride dihydrate)
|
Onetic® 4
|
2 mg/mL (4 mg/2 mL)
|
Solution For Injection (I.M./I.V.)
|
Serotonin (5HT3) Antagonist (Anti-emetic)
|
PT. Pratapa Nirmala
|
Indonesia
|
Initial
|
04 March 2022
|
04 March 2027
|
| View |
|
DRP-11333
|
Darunavir
|
Nurad 800
|
800 mg
|
Film-Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Laurus Labs Limited
|
India
|
Monitored Release
|
02 March 2022
|
02 March 2025
|
| View |
|
DRP-11356
|
Darunavir
|
Nurad 600
|
600 mg
|
Film-Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Laurus Labs Limited
|
India
|
Monitored Release
|
03 March 2022
|
03 March 2025
|
| View |
|
DRP-11364
|
Darunavir
|
Nurad 400
|
400 mg
|
Film-Coated Tablet
|
Antiviral (Protease Inhibitor)
|
Laurus Labs Limited
|
India
|
Monitored Release
|
03 March 2022
|
03 March 2025
|
| View |
|
DR-XY47776
|
Cholecalciferol
|
None
|
60,000 IU
|
Chewable Tablet
|
Vitamin
|
Tirupati Medicare Limited
|
India
|
Initial
|
04 March 2022
|
04 March 2027
|