| View |
|
DR-XY47482
|
Lamotrigine
|
Lanistor
|
100 mg
|
Tablet
|
-
|
Kusum Healthcare Private Limited
|
India
|
Initial
|
21 October 2021
|
21 October 2026
|
| View |
|
DR-XY47483
|
Lamotrigine
|
Lanistor
|
25mg
|
Tablet
|
-
|
Kusum Healthcare Private Limited
|
India
|
Initial
|
21 October 2021
|
21 October 2026
|
| View |
|
DRP-10625
|
Sitagliptin (as phosphate)
|
Januvis
|
25mg
|
Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
-
|
28 October 2021
|
28 October 2026
|
| View |
|
DRP-10624
|
Sitagliptin (as phosphate)
|
Januvis
|
50mg
|
Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
-
|
28 October 2021
|
28 October 2026
|
| View |
|
DRP-10623
|
Sitagliptin (as phosphate)
|
Januvis
|
100 mg
|
Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
-
|
28 October 2021
|
28 October 2026
|
| View |
|
DRP-10621
|
Granisetron (as hydrochloride)
|
Granon
|
1 mg/mL
|
Solution For Injection (Iv)
|
-
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
-
|
28 October 2021
|
28 October 2026
|
| View |
|
DRP-10622
|
Granisetron (as hydrochloride)
|
Granon
|
1 mg/mL
|
Solution For Injection (Iv)
|
-
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
-
|
28 October 2021
|
28 October 2026
|
| View |
|
DR-XY 44353
|
Perampanel
|
Fycompa
|
2mg
|
Film-Coated Tablet
|
-
|
Eisai Manufacturing Limited
|
United Kingdom
|
Initial from Monitored Release]
|
19 October 2021
|
24 March 2025
|
| View |
|
DR-XY 44354
|
Perampanel
|
Fycompa
|
4mg
|
Film-Coated Tablet
|
-
|
Eisai Manufacturing Limited
|
United Kingdom
|
Initial from Monitored Release]
|
19 October 2021
|
24 March 2025
|
| View |
|
DRP-10597
|
Rosuvastatin (As Calcium)
|
Fusovast
|
20 mg
|
Film-Coated Tablet
|
-
|
Sava Healthcare Ltd.
|
India
|
-
|
21 October 2021
|
21 October 2026
|
| View |
|
DR-XY47464
|
Caspofungin (as acetate)
|
Fungicas
|
50 mg
|
Lyophilized Powder for Concentrate Solution
for IV Infusion
|
-
|
Mylan Laboratories Limited
|
India
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
DR-XY47465
|
Caspofungin (as acetate)
|
Fungicas
|
70 mg
|
Lyophilized Powder for Concentrate Solution
for IV Infusion
|
-
|
Mylan Laboratories Limited
|
India
|
-
|
15 October 2021
|
15 October 2026
|
| View |
|
DRP-10426
|
Febuxostat
|
Fexuric
|
40 mg
|
Film-Coated Tablet
|
Antigout
|
Gracure Pharmaceuticals Ltd
|
India
|
Initial
|
04 November 2021
|
04 November 2026
|
| View |
|
DRP-10595
|
Carboprost (as trometamol)
|
Evaprost
|
250 mcg/mL (as 125 mcg/0.5 mL and as 250 mcg/mL)
|
Solution for Intramuscular Injection
|
Uterotonic (Prostaglandin)
|
Celon Laboratories Private Limited
|
India
|
Renewal
|
29 February 2024
|
13 March 2029
|
| View |
|
DRP-10646
|
Esomeprazole (as sodium)
|
Esomestad
|
40mg
|
Lyophilized Powder for Injection for I.V. Infusion
|
Proton Pump Inhibitor
|
Hemofarm A.D.
|
Serbia
|
Automatic Renewal
|
12 October 2022
|
15 December 2027
|
| View |
|
DR-XY47511
|
Esomeprazole (as sodium)
|
Genium
|
40 mg
|
Lyophilized Powder for I.V. Infusion
|
Proton Pump Inhibitor
|
Gen İlaç VE Sağlik Ürünleri San. Ve Tic. Aş.
|
Turkey
|
Initial
|
04 November 2021
|
04 November 2026
|
| View |
|
DRP-10586
|
Zoledronic Acid (as monohydrate)
|
Dronate
|
4mg/5mL
|
Concentrate Solution for IV Infusion
|
-
|
USV Private Limited
|
India
|
-
|
20 October 2021
|
20 October 2026
|
| View |
|
DR-XY47486
|
Doxofylline
|
Doxopro
|
400 mg
|
Tablet
|
Bronchodilator
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 October 2021
|
22 October 2026
|
| View |
|
DR-XY47485
|
Doxofylline
|
Doxair
|
400 mg
|
Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
22 October 2021
|
22 October 2026
|
| View |
DRP-10616_PI_01.pdf
|
DRP-10616
|
Docetaxel
|
Docelex
|
40mg/mL
|
Concentrate Solution For IV Infusion
|
Antineoplastic
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
29 October 2021
|
29 October 2026
|