| View |
|
DRP-16255
|
Eplerenone
|
Eplephil-50
|
50 mg
|
Film Coated Tablet
|
Aldosterone antagonist
|
Globela Pharma Private Limited
|
India
|
Initial
|
10 January 2025
|
10 January 2030
|
| View |
|
DRP-16295
|
Mupirocin
|
Mupirtect
|
20 mg/g (2% w/w)
|
Topical Ointment
|
Antibacterial
|
Orbit Pharmaceuticals
|
India
|
Initial
|
28 January 2025
|
28 January 2030
|
| View |
|
DRP-16244
|
Simeticone
|
Cosimetz
|
40 mg/mL
|
Suspension (Oral Drops)
Flavor)
|
Gastrointestinal Drug (Antiflatulent)
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
09 January 2025
|
09 January 2030
|
| View |
|
DRP-16269
|
Mupirocin
|
Bacticin
|
20 mg/g (2% w/w)
|
Ointment
|
Antibacterial
|
Next Wave (India)
|
India
|
Initial
|
17 January 2025
|
17 January 2030
|
| View |
|
DRP-16248
|
Simeticone
|
Simegas
|
40 mg
|
Chewable Tablet
|
Antiflatulent
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
10 January 2025
|
10 January 2030
|
| View |
|
DRP-16249
|
Calcium Sennosides
|
Sennanov
|
13.5 mg
|
Tablet
|
Laxative
|
West-Coast Pharmaceutical Works Ltd.
|
India
|
Initial
|
10 January 2025
|
10 January 2030
|
| View |
|
DR-XY49316
|
Paracetamol
|
Racetol
|
500 mg
|
Tablet
|
Analgesic/Antipyretic
|
Acies Pharmaceutical Pvt. Ltd.
|
India
|
Initial
|
10 January 2025
|
10 January 2027
|
| View |
|
DRP-16266
|
Sultamicillin (as tosylate)
|
Talmicillin
|
750 mg
|
Film Coated Tablet
|
Antibacterial (Penicillin).
|
Sarthi Pharma
|
India
|
Initial
|
16 January 2025
|
16 January 2030
|
| View |
|
DRP-16267
|
Sultamicillin (as tosylate)
|
Talmicillin
|
375 mg
|
Film Coated Tablet
|
Antibacterial (Penicillin)
|
Sarthi Pharma
|
India
|
Initial
|
16 January 2025
|
16 January 2030
|
| View |
|
DR-XY49317
|
Furosemide
|
Siti-Furose
|
10mg/mL (20mg/2mL)
|
Solution for Injection (IM/IV)
|
Diuretic
|
TianJin King York Group HuBei TianYao Pharmaceutical Co., Ltd.
|
China
|
Initial
|
10 January 2025
|
10 January 2030
|
| View |
|
DR-XY49319
|
Rocuronium Bromide
|
Kabiroc
|
10 mg/mL
|
Solution for Injection (IV)
|
Muscle Relaxant
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial
|
28 January 2025
|
28 January 2030
|
| View |
|
DR-XY49321
|
Sugammadex
|
Sugamex
|
100 mg/mL
|
Solution for Injection (IV)
|
Antidote
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial
|
28 January 2025
|
28 January 2030
|
| View |
|
DRP-16283
|
Apixaban
|
Apixero 5
|
5 mg
|
Film Coated Tablet
|
Direct Factor Xa inhibitor
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
27 January 2025
|
27 January 2030
|
| View |
|
DRP-16284
|
Apixaban
|
Apixero 2.5
|
2.5 mg
|
Film Coated Tablet
|
Direct Factor Xa inhibitor
|
Hetero Labs Limited (Unit V)
|
India
|
Initial
|
27 January 2025
|
27 January 2030
|
| View |
|
DRP-15912
|
Vildagliptin
|
Cadiglip 50
|
50 mg
|
Tablet
|
Oral Hypoglycemic (DPP-4) Inhibitor
|
Cadilla Pharmaceuticals Limited.
|
India
|
Initial Correction]
|
23 January 2025
|
30 September 2029
|
| View |
|
DR-XY49244
|
Vancomycin (as hydrochloride)
|
Pol-Vanco
|
1 g
|
Lyophilized Powder for Injection for I.V. Infusion
|
Antibacterial (Glycopeptide)
|
Aroma İlaç Sanayi. Ltd. ŞTİ.
|
Turkey
|
Initial (Reapplication) (Correction)
|
28 October 2025
|
08 October 2029
|
| View |
|
DR-XY49245
|
Vancomycin (as hydrochloride)
|
Pol-Vanco
|
500 mg
|
Powder for Injection for I.V. Infusion
|
Antibacterial (Glycopeptide)
|
Aroma İlaç Sanayi. Ltd. ŞTİ.
|
Turkey
|
Initial (Reapplication) (Correction)
|
28 January 2025
|
08 October 2029
|
| View |
|
DRP-16304
|
Celecoxib
|
Emicox-400
|
400 mg
|
Capsule
|
Non-Steroid Anti-inflammatory and Anti-rheumatic.
Product (Coxib)
|
Baroque Pharmaceuticals Pvt Ltd.
|
India
|
Initial
|
31 January 2025
|
31 January 2030
|
| View |
|
DRP-16303
|
Celecoxib
|
Emicox
|
200 mg
|
Capsule
|
Non-Steroid Anti-inflammatory and Anti-rheumatic Product (Coxib)
|
Baroque Pharmaceuticals Pvt Ltd.
|
India
|
Initial
|
31 January 2025
|
31 January 2030
|
| View |
|
DRP-16311
|
Silver Sulfadiazine
|
Agyzide
|
10 mg/g (1% w/w)
|
Topical Cream
|
Antibacterial (Sulfonamide)
|
Nanz Med Science Pharma Pvt. Ltd.
|
India
|
Initial (Reapplication)
|
04 February 2025
|
04 February 2030
|