| View |
|
DR-XY48795
|
Rivaroxaban
|
Xafariv 20
|
20 mg
|
Film-Coated Tablet
|
-
|
Mylan Laboratories Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48796
|
Losartan Potassium
|
Angisartan
|
50mg
|
Film-Coated Tablets
|
-
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48797
|
Fluticasone Furoate
|
Avamys
|
27.5 mcg/actuation
|
Suspension for Nasal Spray
|
-
|
Glaxo Wellcome S.A
|
Spain
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48798
|
Metformin hydrochloride
|
None
|
1 g
|
Extended-Release Tablet
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48799
|
Fulvestrant
|
Fresetran
|
50mg/mL (250 mg/5 mL)
|
Solution for Injection (IM)
|
-
|
Laboratorios Farmalan S.A.
|
Spain
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48800
|
Metformin Hydrchloride
|
Panfor Pr-500
|
500 mg
|
Prolonged-Release Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48801
|
Candesartan cilexetil
|
Aiiracan 16
|
16mg
|
Tablet
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48802
|
Candesartan Cilexetil
|
Aiiracan 8
|
8mg
|
tablet
|
Angiotension II Receptor Antagonist
|
Unison Laboratories Co., Ltd
|
Thailand
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48803
|
Racecadotril
|
Rasec
|
30 mg
|
Granules for Oral Solution
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48804
|
Racecadotril
|
Rasec
|
10 mg
|
Granules For Oral Solution
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2023
|
30 June 2028
|
| View |
|
DR-XY48805
|
Esomeprazole (as magnesium trihydrate)
|
Esmazo;
|
40mg
|
Enteric-Coated Tablet
|
-
|
Lee Pharma Limited
|
India
|
Initial
|
30 June 2023
|
30 June 2025
|
| View |
|
DR-XY48806
|
Apixaban
|
Xagulant 2.5
|
2.5 mg
|
Film-Coated Tablet
|
Direct factor Xa Inhibitor
|
Mylan Laboratories Limited
|
India
|
initial
|
07 July 2023
|
07 July 2028
|
| View |
|
DR-XY48807
|
Apixaban
|
Xagulant 5
|
5 mg
|
Film-Coated Tablet
|
Antithrombotic Agent
|
Mylan Laboratories Limited.
|
India
|
Initial
|
07 July 2023
|
07 July 2028
|
| View |
|
DR-XY48808
|
Methylcobalamin (Vitamin B12)
|
Mecovit
|
500 mcg
|
Tablet
|
-
|
Viva Pharmaceuticals Inc.
|
Canada
|
Initial (OTC)
|
11 July 2023
|
11 July 2028
|
| View |
|
DR-XY48809
|
Nebivolol (as hydrochloride)
|
Nebstyle 5
|
5mg
|
Tablet
|
-
|
Aurobindo Pharma Limited (Unit III)
|
India
|
Initial
|
12 July 2023
|
12 July 2028
|
| View |
|
DR-XY48810
|
Cabazitaxel
|
Cabxel
|
60 mg/1.5 mL
|
Concentrate for Solution for IV Infusion
|
-
|
Hetero Labs Limited (Unit-VI)
|
India
|
Initial
|
12 July 2023
|
12 July 2028
|
| View |
|
DR-XY48811
|
Rivaroxaban
|
Xaroban
|
20 mg
|
Film-Coated Tablet
|
-
|
The Searle Company Limited
|
Pakistan
|
Initial
|
14 July 2023
|
14 July 2028
|
| View |
|
DR-XY48812
|
Pregabalin
|
Nervica 25
|
25 mg
|
Capsule
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial (Reapplication)
|
21 July 2023
|
21 July 2028
|
| View |
|
DR-XY48813
|
Pregabalin
|
Nervica 75
|
75 mg
|
Capsule
|
-
|
Unison Laboratories Co., Ltd.
|
Thailand
|
Initial (Reapplication)
|
21 July 2023
|
21 July 2028
|
| View |
|
DR-XY48814
|
Vildagliptin
|
Vigliptic-50
|
50 mg
|
Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Next Wave (India)
|
India
|
Initial
|
17 July 2023
|
17 July 2028
|