| View |
|
DR-XY47709
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Fosular
|
1g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin / Beta-Lactamase
Inhibitor)
|
PT. Etercon Pharma
|
Indonesia
|
Initial
|
10 March 2022
|
28 February 2027
|
| View |
|
DRP-11361
|
Cefuroxime (as sodium)
|
Furimax
|
750mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 March 2022
|
04 March 2027
|
| View |
|
DRP-11352
|
Imatinib (as mesilate)
|
Imalek 400
|
400 mg
|
Film-Coated Tablet
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-11355
|
Sevelamer Carbonate
|
Sevlarsaph
|
800 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
-
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-11330
|
Rosuvastatin (As Calcium)
|
Rosusaph-10
|
10 mg
|
Film coated tablet
|
HMG COA Reductase Inhibitor
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
03 March 2022
|
03 March 2027
|
| View |
|
DRP-9637
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Zopian-4.5
|
4 g/500 mg
|
Powder For IV Infusion
|
ANTIBACTERIAL (PENICILLIN/BETA-LACTAMASE INHIBITOR)
|
Injectcare Parenterals Pvt. Ltd.
|
India
|
Initial
|
28 February 2022
|
23 April 2026
|
| View |
|
DRP-9638
|
Piperacillin (as sodium) + Tazobactam (as sodium)
|
Zopian-2.25
|
2 g/250 mg
|
Powder For IV Infusion
|
ANTIBACTERIAL (PENICILLIN/BETA-LACTAMASE INHIBITOR)
|
Injectcare Parenterals Pvt Ltd
|
India
|
Initial
|
28 February 2022
|
23 April 2026
|
| View |
|
DRP-11294
|
Ceftriaxone (as Sodium)
|
Suritricef-1000
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Yeluri Formulations Pvt. Ltd.
|
India
|
-
|
28 February 2022
|
22 November 2026
|
| View |
|
DRP-11298
|
Thiamine mononitrate (Vitamin B1) + Pyridoxine
hydrochloride (Vitamin B6) + Cyanocobalamin
(Vitamin B12)
|
GoNerve
|
300 mg/100 mcg/100 mcg
|
Capsule
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
28 February 2022
|
23 November 2026
|
| View |
|
DRP-11303
|
Sildenafil (As Citrate)
|
Siagra
|
25 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
02 March 2022
|
24 November 2026
|
| View |
|
DRP-11301
|
Sildenafil (As Citrate)
|
Robust S
|
25 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
02 March 2022
|
24 November 2026
|
| View |
|
DRP-11304
|
Capecitabine
|
Pacsita 150
|
150 mg
|
Film-Coated Tablet
|
-
|
Eugia Pharma Specialties Limited Survey
|
India
|
-
|
02 March 2022
|
01 December 2026
|
| View |
|
DRP-11297
|
Thiamine mononitrate (Vitamin B1) + Pyridoxine
Hydrochloride (Vitamin B6) + Cyanocobalamin
(Vitamin B12)
|
None
|
300 mg/ 100 mg/ 100 mcg
|
Capsule
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
28 February 2022
|
22 November 2026
|
| View |
|
DRP-11300
|
Sildenafil (As Citrate)
|
None
|
25 mg
|
FILM-COATED TABLET
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
02 March 2022
|
24 November 2026
|
| View |
|
DRP-11305
|
Capecitabine
|
None
|
150 mg
|
Film-Coated Tablet
|
-
|
Eugia Pharma Specialties Limited Survey
|
India
|
-
|
02 March 2022
|
29 November 2026
|
| View |
|
DRP-11306
|
Capecitabine
|
None
|
500 mg
|
Film-Coated Tablet
|
-
|
Eugia Pharma Specialties Limited
|
India
|
-
|
02 March 2022
|
29 November 2026
|
| View |
|
DRP-11299
|
Rocuronium Bromide
|
None
|
10 mg/mL
|
Solution for Injection (IV)
|
Muscle Relaxant
|
Aspiro Pharma Limited
|
India
|
Initial
|
02 March 2022
|
24 November 2026
|
| View |
|
DRP-11302
|
Sildenafil (As Citrate)
|
Erecta
|
25 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
02 March 2022
|
24 November 2026
|
| View |
|
DRP-11307
|
Sodium bicarbonate
|
Bicarbisaph
|
84 mg/mL (8.4% w/v)
|
Solution for Injection (I.V.
Infusion)
|
Electrolyte Replenisher/ Systemic Alkalinising Agent
|
Kilitch Drugs (India) Ltd.
|
India
|
-
|
28 February 2022
|
23 November 2026
|
| View |
|
DRP-9855
|
Etoricoxib
|
Ricox
|
60 mg
|
Film-Coated Tablet
|
-
|
Saga Lifesciences Limited
|
India
|
-
|
03 March 2022
|
05 June 2025
|