| View |
|
DRP-12373
|
Bosentan (as monohydrate)
|
Bosetan-125
|
125 mg
|
Film-Coated Tablet
|
Antihypertensive
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
27 July 2022
|
27 July 2027
|
| View |
|
DRP-12374
|
Bosentan (as monohydrate)
|
Bosetan-62.5
|
62.5 mg
|
Film-Coated Tablet
|
Antihypertensive
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
27 July 2022
|
27 July 2027
|
| View |
|
HRP-531
|
Phyllanthus niruri L.
|
Stimuno (Orange Berry Flavor)
|
25 mg/5 mL
|
Syrup
|
Herbal Medicine (Immunomodulator)
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
28 July 2022
|
28 July 2027
|
| View |
|
DR-XY48225
|
Levetiracetam
|
Levitra
|
1 g
|
Film Coated Tablet
|
Antiepileptic
|
Micro Labs Limited
|
India
|
Initial
|
26 July 2022
|
26 July 2027
|
| View |
|
DRP-12375
|
Pregabalin
|
Pevesca
|
150 mg
|
Capsule
|
Antiepileptic
|
İlko İlaç San. Ve Tic.A.S.
|
Turkey
|
Initial
|
28 July 2022
|
28 July 2027
|
| View |
|
DRP-12376
|
Pregabalin
|
Pevesca
|
300 mg
|
Capsule
|
Antiepileptic
|
İlko İlaç San. Ve Tic.A.S.
|
Turkey
|
Initial
|
28 July 2022
|
28 July 2027
|
| View |
|
DRP-12377
|
Pregabalin
|
Pevesca
|
75 mg
|
Capsule
|
Antiepileptics
|
İlko İlaç San. Ve Tic.A.S.
|
Turkey
|
Initial
|
28 July 2022
|
28 July 2027
|
| View |
|
DRP-12346
|
Levetiracetam
|
Kepdin
|
100 mg/mL
|
Oral Solution
|
Antiepileptic
|
Lifesquare Laboratories Inc.
|
Philippines
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
|
DR-XY48206
|
Omeprazole (as sodium)
|
Omebloc
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Zee Laboratories Limited
|
India
|
Initial
|
20 July 2022
|
20 July 2027
|
| View |
|
DRP-12378
|
Acetylcysteine
|
None
|
600 mg
|
Granules for Oral Solution
|
Mucolytic
|
Bilim İlaç San. Ve Tic. A.Ş.
|
Turkey
|
Initial
|
28 July 2022
|
28 July 2027
|
| View |
|
DRP-12370
|
Irinotecan hydrochloride (as trihydrate)
|
Imatiplex
|
20 mg/mL (100 mg/5 mL)
|
Concentrate Solution for I.V.
Infusion
|
Antineoplastic (Topoisomerase 1 (TOP 1) Inhibitor)
|
Shilpa Medicare Limited - Unit 4 Pharmaceutical Formulation Sez
|
India
|
Initial
|
27 July 2022
|
27 July 2027
|
| View |
|
DRP-12366
|
Mesna
|
None
|
100 mg/mL
|
Solution for Injection (IV)
|
Detoxifying agent for antineoplastic treatment
|
Sakar Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 July 2022
|
26 July 2027
|
| View |
|
DRP-12365
|
Levetiracetam
|
Focale
|
500 mg / 5 mL
|
Concentrate for Solution for IV Infusion
|
Antiepileptic
|
Pharmathen SA
|
Greece
|
Initial (Correction)
|
17 January 2023
|
26 July 2027
|
| View |
|
DRP-12343
|
Dutasteride + Tamsulosin Hydrochloride
|
Hiperdext Plus
|
500 mcg/ 400 mcg
|
Capsule
|
Benign Prostatic Hypertrophy Drug (Alpha-adrenoceptor
Antagonist)
|
Laboratorios Leon Farma S.A
|
Spain
|
Initial
|
21 July 2022
|
21 July 2027
|
| View |
|
DRP-12364
|
Ceftazidime (as pentahydrate)
|
Zidime
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Cephalosporin)
|
Makcur Laboratories Limited
|
India
|
Initial (Correction)
|
04 October 2022
|
25 July 2027
|
| View |
|
DRP-12350
|
Ceftriaxone (as sodium)
|
Trixsur
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (third-generation cephalosporin)
|
Zhuhai United Laboratories (Zhongshan) Co., Ltd.
|
China
|
Initial
|
22 July 2022
|
22 July 2027
|
| View |
DR-XY48216_PI_01.pdf
|
DR-XY48216
|
Pomalidomide
|
Pomadex 1
|
1 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2025
|
| View |
DR-XY48217_PI_01.pdf
|
DR-XY48217
|
Pomalidomide
|
Pomadex 2
|
2 mg
|
Capsule
|
-
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
21 July 2022
|
21 July 2025
|
| View |
DR-XY48207_PI_01.pdf
|
DR-XY48207
|
Pomalidomide
|
Pomadex 4
|
4 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
20 July 2022
|
20 July 2025
|
| View |
DR-XY48208_PI_01.pdf
|
DR-XY48208
|
Pomalidomide
|
Pomadex 3
|
3 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block-VB)
|
India
|
Monitored Release
|
20 July 2022
|
20 July 2025
|