| View |
|
DR-XY48798
|
Metformin hydrochloride
|
None
|
1 g
|
Extended-Release Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DRP-14662
|
Thiamine Hydrochloride (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin. (Vitamin B12)
|
Berrinerve
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection.
(IM)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
17 November 2023
|
17 November 2028
|
| View |
|
DRP-14004
|
Quetiapine (as fumarate)
|
Siquapine XR
|
50 mg
|
Prolonged-Release Tablet
|
-
|
Pharmathen International S.A.
|
Greece
|
Initial
|
02 June 2023
|
02 June 2028
|
| View |
|
DRP-14642
|
Linezolid
|
Acuzolid
|
2 mg/mL (600 mg/300 mL)
|
Solution for IV Injection.
|
-
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DRP-14650
|
Esomeprazole (as sodium)
|
Moreso-40
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
-
|
Mason Pharma
|
India
|
Initial
|
15 November 2023
|
15 November 2028
|
| View |
|
DR-XY48928
|
Memantine Hydrochloride
|
Alzhemed 20
|
20 mg
|
Film-Coated Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
22 November 2023
|
22 November 2028
|
| View |
|
DRP-14695
|
Donepezil hydrochloride (as monohydrate)
|
Azimentia
|
10 mg
|
Orodispersible Tablet
|
-
|
KRKA, D.D., Novo Mesto
|
Slovenia
|
Initial
|
29 November 2023
|
29 November 2028
|
| View |
|
DRP-14719
|
Donepezil Hydrochloride
|
Azimentia
|
5 mg
|
Orodispersible Tablet
|
-
|
KRKA, D.D., Novo Mesto
|
Slovenia
|
Initial
|
04 December 2023
|
04 December 2028
|
| View |
|
DR-XY48945
|
Dapagliflozin
|
Invaflozin 10
|
10mg
|
Film-Coated Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
14 December 2023
|
14 December 2028
|
| View |
|
DRHR-2319
|
Methyl Salicylate + Camphor + Menthol
|
H & H Therament
|
12 g/12 g / 11 g per 100 mL
|
Liniment
|
-
|
A.M. Rieta Corporation.
|
Philippines
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14740
|
Quetiapine (as fumarate)
|
Nervas
|
25 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14355
|
Clonidine hydrochloride.
|
Lonid 75
|
75 mcg
|
Tablet
|
-
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
31 August 2023
|
31 August 2025
|
| View |
|
DR-XY48931
|
Pemetrexed (as disodium hemipentahydrate)
|
Pemtrex
|
10 mg/mL (500 mg/50 mL)
|
Solution for Injection
(IV Infusion)
|
-
|
Shilpa Medicare Limited (Unit. 4, Pharmaceutical Formulations Sez)
|
India
|
Monitored Release (MR)
|
23 November 2023
|
23 November 2028
|
| View |
|
DR-XY48920
|
Cefuroxime (as sodium)
|
Meurox
|
1.5 g
|
Powder for Injection (IM/IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
16 November 2023
|
16 November 2028
|
| View |
|
DR-XY48948
|
Ceftazidime
|
None
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DR-XY48950
|
Ceftriaxone (as sodium)
|
None
|
2 g
|
Powder For Injection (IM/IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14689
|
Sitagliptin (as phosphate monohydrate)
|
Si2norm
|
50 mg
|
Film-Coated Tablet
|
-
|
National Healthcare Pvt., Ltd.
|
Nepal
|
Initial
|
23 November 2023
|
23 November 2028
|
| View |
|
DR-XY48919
|
Cefuroxime (as sodium)
|
Feroxim
|
750 mg
|
Powder for Injection (IM/IV
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
16 November 2023
|
16 November 2028
|
| View |
|
DR-XY48914
|
Cefoxitin (as sodium)
|
Trexin
|
1 g
|
Powder for Injection (IV)
|
-
|
Vellinton Healthcare
|
India
|
Initial
|
09 November 2023
|
09 November 2028
|
| View |
|
DRP-14167
|
Decitabine
|
Decita
|
50mg
|
Lyophilized Powder For Injection
|
-
|
Jari Pharmaceutical Co., Ltd.
|
China
|
Initial
|
10 July 2023
|
10 July 2028
|