| View |
|
DRP-15811
|
Dexketoprofen (as Trometamol)
|
Profiem
|
25 mg
|
Tablet
|
Non-steroidal Anti-inflammatory/Antirheumatic
(Propionic Acid Derivative)
|
Novagen Healthcare Private Limited
|
India
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DRP-15814
|
Amlodipine (as besilate) + Hydrochlorothiazide + Valsartan te) + Hydrochlorothiazide + Valsartan
|
Ameval Plus
|
10mg/25mg/320mg
|
Film-Coated Tablet
|
Antihypertensive
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DR-XY49211
|
Pantoprazole (as sodium)
|
Oprasenz
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton pump inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DR-XY49209
|
Etoricoxib
|
Etoricon
|
120 mg
|
Film-Coated Tablet
|
Coxib
|
The ACME Laboratories Limited
|
Bangladesh
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15800
|
Vinorelbine (as tartrate)
|
Prorelbine
|
30 mg
|
Softgel Capsule
|
Vinca Alkaloid and Analogue.
|
Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
(Workshop HS108)
|
China
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15792
|
Meropenem (as trihydrate)
|
Meroparm
|
1 g
|
Powder for Solution for IV Injection/Infusion
|
Carbapenem
|
Anfarm Hellas S.A
|
Greece
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15790
|
Metformin Hydrochloride
|
Xrmin ER 500
|
500 mg
|
Extended-Release Tablet
|
Biguanide
|
Exemed Pharmaceuticals
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15791
|
Metformin Hydrochloride
|
Xrmin ER 1000.
|
1 g
|
Extended-Release Tablet
|
Biguanide
|
Exemed Pharmaceuticals
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15793
|
Metformin Hydrochloride
|
Glycemin
|
500 mg
|
Tablet
|
Biguanide
|
Wallace Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DR-XY49210
|
Betamethasone (as dipropionate) + Betamethasone (as) sodium phosphate)
|
Bufencon
|
5 mg/2 mg per mL
|
Suspension for Injection (IM/IA/ID/IL)
|
Anti-inflammatory/ Adrenal Corticosteroid
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15795
|
Betahistine Hydrochloride
|
Betazar
|
8mg
|
Tablet
|
Antivertigo Preparation.
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15797
|
Betahistine Hydrochloride
|
Betazar
|
24 mg
|
Tablet
|
Antivertigo Preparation
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15798
|
Metformin Hydrochloride
|
Sukrivent 500
|
500 mg
|
Prolonged Release Tablet
|
Biguanide
|
Inventia Healthcare Limited
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15799
|
Metformin Hydrochloride
|
Sukrivent 1000
|
1 g
|
Prolonged Release Tablet
|
Biguanide
|
Inventia Healthcare Limited
|
India
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DR-XY49212
|
Rivaroxaban
|
Rivoxa
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Ajanta Pharma Limited
|
India
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DR-XY49214
|
Rivaroxaban
|
Rivoxa
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Ajanta Pharma Limited
|
India
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DR-XY49213
|
Rivaroxaban
|
Rivoxa
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct Factor Xa Inhibitor)
|
Ajanta Pharma Limited.
|
India
|
Initial
|
17 September 2024
|
17 September 2029
|
| View |
|
DRP-15794
|
Norepinephrine (as bitartrate)
|
Neurosenz
|
1 mg/mL (4 mg/ 4 mL)
|
Solution for IV Injection
|
Adrenergic and Dopaminergic Agent
|
Jeil Pharmaceutical Co., Ltd.
|
Korea
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-15821
|
Itraconazole
|
Candifen
|
100 mg
|
Capsule
|
Antifungal (Triazole and tetrazole derivative)
|
Laboratorios Liconsa S.A.
|
Spain
|
Initial
|
18 September 2024
|
18 September 2029
|
| View |
|
DRP-6164-04
|
Cefpodoxime (as Proxetil)
|
Dorexcef
|
200 mg
|
Film-Coated Tablet
|
Antibacterial
|
Brawn Laboratories Limited
|
India
|
CLIDP Conversion
|
15 September 2024
|
22 May 2030
|