| View |
|
DRP-14172
|
Clindamycin (as phosphate)
|
Anticiem
|
150 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Samrudh Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
13 July 2023
|
13 July 2028
|
| View |
|
DRP-14160
|
Ranitidine (As Hydrochloride)
|
Zentek
|
150mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
07 July 2023
|
07 July 2028
|
| View |
|
DRP-14202
|
Cefotaxime (As Sodium)
|
Medzidime
|
1 g
|
Powder For Injection (Im/Iv)
|
-
|
Ananta Medicare Limited
|
India
|
Initial
|
18 July 2023
|
18 July 2028
|
| View |
|
DRP-14173
|
Losartan Potassium + Amlodipine (As Besilate)
|
Saphlodine 100/10
|
100mg/10mg
|
Film Coated Tablets
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Reapplication)
|
13 July 2023
|
13 July 2028
|
| View |
|
DRP-14174
|
Ethambutol Hydrochloride
|
Saphetam-400
|
400 mg
|
Tablet
|
-
|
Bueno Salud Care (India) Pvt. Ltd.
|
India
|
Initial (Reapplication)
|
13 July 2023
|
13 July 2028
|
| View |
|
DRP-14159
|
Ranitidine (As Hydrochloride)
|
Zentek
|
300mg
|
Tablet
|
-
|
Globela Pharma Private 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 |
|
DRP-9609
|
Carbocisteine
|
Saphcisin-100
|
100mg/5mL
|
Syrup
|
Mucolytic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial (OTC)
|
24 March 2021
|
24 March 2026
|
| View |
|
DRP-1375-05
|
Simvastatin
|
None
|
20 mg
|
Film-Coated Tablet
|
Hypercholesterolemia
|
Interphil Laboratories Inc.
|
Philippines
|
Automatic Renewal
|
22 July 2023
|
29 October 2028
|
| View |
|
DRP-2655-20
|
Celecoxib
|
Kairoxib
|
200 mg
|
Capsule
|
Selective COX-2 Inhibitor
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Automatic Renewal
|
15 June 2023
|
20 December 2028
|
| View |
|
DRP-12531-02
|
Losartan Potassium
|
Sartollen 100
|
100 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Renewal
|
14 April 2023
|
02 September 2027
|
| View |
|
DRP-12532-02
|
Losartan Potassium
|
Sartollen 50
|
50 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Renewal
|
11 April 2023
|
02 September 2027
|
| View |
|
DRP-4985-05
|
Oxytocin
|
Oxtolev
|
10IU/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
Posterior Pituitary Hormone
|
Umedica Laboratories Pvt. Ltd.
|
India
|
Automatic Renewal
|
10 June 2023
|
11 December 2028
|
| View |
|
DRP-4948-07
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
None
|
4 g/500 mg per vial
|
Powder for Injection (IV/IM)
|
Antibacterial (Penicillin with Beta-lactamase Inhibitor)
|
Stallion Laboratories Pvt. Ltd.
|
Korea
|
Automatic Renewal
|
07 June 2023
|
22 November 2028
|
| View |
|
DRP-14210
|
Mupirocin
|
None
|
20 mg/g (2% w/w)
|
Topical Ointment
|
-
|
Agio Pharmaceuticals Ltd.
|
India
|
Initial
|
26 July 2023
|
26 July 2028
|
| View |
|
DRP-14204
|
Vildagliptin + Metformin Hydrochloride
|
Vildamet
|
50 mg + 500 mg
|
Film-Coated Tablet
|
-
|
Medisure Laboratories Pakistan (Pvt.) Ltd
|
Pakistan
|
Initial
|
21 July 2023
|
21 July 2028
|
| View |
|
DR-XY48823
|
Digoxin
|
Lanoxin
|
250 mcg
|
Tablet
|
-
|
Aspen Bad Oldesloe GmbH
|
Germany
|
Initial
|
28 July 2023
|
28 July 2028
|
| View |
DR-XY48820_PI_01.pdf
|
DR-XY48820
|
Lurasidone Hydrochloride
|
Latuda
|
20 mg
|
Film-Coated Tablet
|
-
|
Bushu Pharmaceuticals Ltd. (Kawagoe Factory)
|
Japan
|
Monitored Release
|
25 July 2023
|
25 July 2028
|
| View |
|
DRP-14206
|
Cefepime (as hydrochloride)
|
Accepime
|
1 gm
|
Powder for Injection (I.M./I.V.)
|
-
|
Medisure Laboratories Pakistan Pvt Ltd
|
Pakistan
|
Initial (Re-application)
|
21 July 2023
|
21 July 2028
|
| View |
|
DRP-14214
|
Dexketoprofen (As Trometamol)
|
Deccetrol
|
25mg/mL
|
Solution For Injection (IM/IV)
|
-
|
Osel Ilac San Ve Tic A.S.
|
Turkey
|
Initial
|
27 July 2023
|
27 July 2028
|