| View |
|
DRP-13404
|
Glimepiride
|
Norizec
|
3 mg
|
Tablet
|
-
|
PT Darya-Varia Laboratoria TBK
|
Indonesia
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13388
|
Omeprazole (As Sodium)
|
Flazomel
|
40 mg
|
Lyophilized Powder for IV Injection.
|
-
|
Lyka Labs Limited.
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13422
|
Salbutamol (As Sulfate)
|
Bioxal
|
2mg/5mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13391
|
Bleomycin (as Sulfate)
|
Bleomed
|
15 Units
|
Powder For Solutin For Injection (IM/IV/SC)
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
16 February 2023
|
16 February 2028
|
| View |
|
DRP-13431
|
Cefepime (as Hydrochloride)
|
Novafime
|
500mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|
| View |
|
DRP-13400
|
Spironolactone
|
Urinasaph-S
|
25 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13401
|
Zoledronic Acid (as monohydrate)
|
Zometanic
|
4mg / 5mL
|
Concentrate Solution for Intravenous Infusion
|
-
|
Mefar İlaç Sanayii A.Ş.
|
Turkey
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13447
|
Telmisartan
|
Telfocus 40
|
40 mg
|
Tablet
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
Initial
|
22 February 2023
|
22 February 2026
|
| View |
|
DRP-13448
|
Telmisartan
|
None
|
40 mg
|
Tablet
|
-
|
Aurobindo Pharma Limited (Unit VII)
|
India
|
Initial
|
22 February 2023
|
22 February 2026
|
| View |
DRP-13407_PI_01.pdf
|
DRP-13407
|
Paclitaxel
|
Macrotaxel
|
6 mg/mL (260 mg/43.4 mL)
|
Concentrate for Solution for
I.V. Infusion
|
-
|
Venus Remedies Limited
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48626
|
Doxorubicin Hydrochloride
|
None
|
2mg/mL (50mg/25mL)
|
Solution for Injection for I.V.
Infusion
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13427
|
Ceftazidime (as pentahydrate)
|
Demicef
|
1 g
|
Powder For Injection (IM/IV)
|
-
|
Chengdu Brilliant Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
DRP-13418_PI_01.pdf
|
DRP-13418
|
Amitriptyline hydrochloride
|
Amiprasan
|
25 mg
|
Film-Coated Tablet
|
-
|
Sunrise International Labs Limited
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13405
|
Etoricoxib
|
Etrobax 90
|
90 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13406
|
Etoricoxib
|
Etrobax 60
|
60 mg
|
Film-Coated Tablet
|
-
|
Hetero Labs Limited (Unit III)
|
India
|
Initial
|
16 February 2023
|
16 February 2028
|
| View |
|
DR-XY48632
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 500 + 10
|
10 mg/500mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48633
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 1000 + 5
|
5mg/1g
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48631
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 1000 + 10
|
10mg/1g
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48634
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 500 + 5
|
5mg/500mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DRP-13445
|
Gemcitabine (As Hydrochloride)
|
Emcisanz-200
|
200mg
|
Powder For Solution For IV Infusion
|
-
|
Admac Lifesciences
|
India
|
Initial
|
20 February 2023
|
20 February 2028
|