| View |
|
DRP-15893
|
Vildagliptin + Metformin HCl
|
DIPP-4 Plus
|
50 mg/1 g
|
Film-coated Tablet
|
Combination of oral blood glucose lowering drugs
|
BAFNA Pharmaceuticals Limited.
|
India
|
Initial
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15890
|
Vildagliptin
|
Vildaberry 50
|
50 mg
|
Tablet
|
Dipeptidyl Peptidase 4 (DPP-4) Inhibitor
|
Next Wave (India)
|
India
|
Initial
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15891
|
Zoledronic Acid
|
Zoledsaph
|
4 mg per 5 mL
|
Solution for Injection (I.V.)
|
Bisphosphonater
|
Bruck Pharma Private Limited
|
India
|
Initial
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15853
|
Olanzapine
|
Olinbaf-10
|
10 mg
|
Orodispersible Tablet
|
Atypical Antipsychotic
|
Bafna Pharmaceuticals Limited
|
India
|
Initial
|
23 September 2024
|
23 September 2026
|
| View |
|
DR-XY49238
|
Dolutegravir (as sodium)
|
None
|
10 mg
|
Dispersible Tablet
|
Direct Acting Antiviral (Integrase Inhibitor)
|
Macleods Pharmaceuticals Limited
|
india
|
Monitored Release
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15876
|
Pantoprazole (as sodium)
|
Faratop
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Nitin Lifesciences Ltd. (Unit III)
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15854
|
Mycophenolate Mofetil
|
Transtero
|
250 mg
|
Capsule
|
Immunosuppressant
|
Hetero Labs Limited (Unit-V, Block- VB)
|
India
|
Initial (Reapplication)
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-15892
|
Fluconazole
|
Aploxol
|
150 mg
|
Capsule
|
Antimycotics for Systematic Use (Triazole and Tetrazole Derivative)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
26 September 2024
|
26 September 2029
|
| View |
|
DRP-15771
|
Cefepime (as hydrochloride)
|
Ivipime
|
1 g
|
Powder for Injection (IV)
|
Antibacterial (Cephalosporin)
|
VHB Medi Sciences Limited
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15424
|
Enzalutamide
|
Enzaphil-40
|
40 mg
|
Capsule
|
Anti-androgen (Androgen Receptor Antagonist)
|
Globela Pharma Private Limited
|
India
|
Initial
|
20 September 2024
|
20 September 2029
|
| View |
|
DRP-15879
|
Pantoprazole (as sodium)
|
Bantopraz
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Rhydburg Pharmaceuticals Limited.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15880
|
Pantoprazole (as sodium)
|
Sunpant 40
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
Rhydburg Pharmaceuticals Limited.
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15882
|
Paclitaxel
|
Maclitax
|
6 mg/mL (30 mg/5 mL)
|
Solution for Injection (IV)
|
Antineoplastic Agent (Taxane)
|
Cisen Pharmaceutical Co., Ltd.
|
China
|
Initia
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15883
|
Ondansetron hydrochloride
|
Beludan-4
|
4 mg/mL
|
Solution for Injection (I.M./I.V.)
|
Anti-emetic
|
Hiral Labs Limited
|
India
|
Initial
|
25 September 2024
|
25 September 2029
|
| View |
|
DR-XY49228
|
Pemetrexed (as disodium hemipentahydrate)
|
None
|
500 mg
|
Lyophilized Powder for IV Injection
|
Antineoplastic (Folic acid analogue)
|
Venus Remedies, Limited
|
India
|
Initial (Re-application)
|
24 September 2024
|
24 September 2029
|
| View |
|
DRHR-2379
|
Ethyl Alcohol
|
None
|
70 ml per 100 ml (70% v/v)
|
Topical Solution
|
Antiseptic/Disinfectant
|
Kohl Industries Corporation
|
Philippines
|
Initial
|
20 September 2024
|
20 September 2026
|
| View |
|
DRP-15809
|
Betahistine (as hydrochloride)
|
Betazak-8
|
8 mg
|
Tablet
|
Antivertigo preparation
|
Schazoo Zaka (Pvt.) Ltd.
|
Pakistan
|
Initial
|
23 September 2024
|
23 September 2029
|
| View |
|
DRP-15850
|
Ascorbic Acid + Zinc
|
None
|
1 g (equivalent to 1.125 g Sodium Ascorbate)/35 mg
(equivalent to 243.94 mg Zinc Gluconate)
|
Film-coated tablet
|
Vitamin/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15851
|
Ascorbic Acid + Zinc
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/10 mg (equivalent to 70 mg Zinc Gluconate)
|
Film-Coated Tablet
|
Vitamin/Mineral
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
25 September 2024
|
25 September 2029
|
| View |
|
DRP-15848
|
Ketoconazole
|
Ketovenasol
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal for Topical Use (Imidazole and Triazole)
|
Gracure Pharmaceuticals Ltd.,
|
India
|
Initial
|
23 September 2024
|
23 September 2029
|