| View |
|
DRP-10823
|
Rosuvastatin (As Calcium)
|
Kingstat 20
|
20 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitors
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
03 December 2021
|
03 December 2026
|
| View |
|
DRP-10820
|
Rosuvastatin (As Calcium)
|
Kingstat 10
|
10 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Sun Pharmaceutical Industries Limited.
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
03 December 2026
|
| View |
|
DRP-5305
|
Ketoprofen
|
Ketomax
|
50mg
|
Capsule
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Automatic Renewal (Re-issuance)
|
03 August 2022
|
27 September 2026
|
| View |
|
DRP-10851
|
Amlodipine (as Besilate)
|
Golvasc
|
5 mg
|
Film-Coated tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10850
|
Amlodipine (as Besilate)
|
Golvasc
|
10 mg
|
Film-Coated tablet
|
Antihypertensive (Calcium channel blocker)
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-5177
|
Esomeprazole (as sodium)
|
Esoget
|
40 mg
|
Lyophilized Powder for IV Injection/Infusion
|
Proton Pump Inhibitor
|
Sovereign Pharma Pvt. Ltd.
|
India
|
Renewal
|
22 November 2023
|
20 February 2029
|
| View |
|
DRP-5676-03
|
Clindamycin (as phosphate)
|
Clindalon
|
150 mg/mL
|
Solution For Injection (IM/IV)
|
Antibacterial
|
Alvita Pharma Private Limited
|
India
|
Renewal
|
29 June 2024
|
29 October 2029
|
| View |
|
DRP-6259
|
Losartan Potassium + Hydrochlorothiazide
|
Artazide
|
50 mg/12.5 mg
|
Film-Coated Tablet
|
Antihypertensive
|
Pharmatec Pakistan (Pvt.) Ltd.
|
Pakistan
|
Renewal
|
25 July 2024
|
05 September 2029
|
| View |
|
DR-XY47581
|
Efavirenz
|
Efavir
|
600 mg
|
Film Coated Tablet
|
Antiviral (Non-Nucleoside Reverse Transcriptase
Inhibitor)
|
Cipla Limited - Goa (Unit IV)
|
India
|
Initial
|
07 December 2021
|
07 December 2024
|
| View |
|
DRP-664-02
|
Ambroxol hydrochloride
|
None
|
30 mg/ 5mL
|
Syrup
|
Mucolytic
|
Am-Europharma Corporation
|
Philippines
|
Automatic Renewal
|
06 December 2021
|
17 February 2025
|
| View |
|
DRP-10847
|
Tirofiban (as hydrochloride monohydrate)
|
Tigrastat
|
250 mcg/mL (12.5 mg/50 mL)
|
Concentrate For Solution For I.V. Infusion
|
Platelet Aggregation Inhibitor
|
Mefar Ilac Sanayii A.S.
|
Turkey
|
Initial
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10855
|
Cefuroxime (As Sodium)
|
Cefukon-750
|
750 mg
|
Powder For Injection (Im/Iv)
|
Antibacterial (Cephalosporin)
|
Sance Laboratories Private Limited
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47580
|
Propofol
|
Folanes
|
10 mg/mL (1% w/v)
|
Emulsion for Injection
(I.V./Infusion)
|
General Anesthetic (Short-acting Anesthetic)
|
Dongkook Pharmaceutical Co., Ltd.
|
Korea
|
Initial (Re-Issuance)
|
02 August 2022
|
03 December 2026
|
| View |
|
DR-XY47583
|
Lamivudine + Zidovudine + Nevirapine
|
Duovir-N
|
150 mg/300 mg/200 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Goa (Unit VII)
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47582
|
Dolutegravir (as sodium)
|
Santigrase
|
50 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Indore SEZ (Unit IV)
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47584
|
Efavirenz + Emtricitabine + Tenofovir disoproxil
fumarate
|
Viraday
|
600 mg/200 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Cipla Limited - Goa (Unit VII)
|
India
|
Monitored Release
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47585
|
Efavirenz + Emtricitabine + Tenofovir disoproxil
fumarate
|
Trioday
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
-
|
Cipla Limited - Goa (Unit VII)
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DRP-10888
|
Cefuroxime (as sodium)
|
Cefunova
|
750 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
DR-XY47589
|
Dolutegravir (as sodium) + Lamivudine + Tenofovir
disoproxil fumarate
|
None
|
50 mg/300 mg/300 mg
|
Film Coated Tablet
|
-
|
Cipla Limited
|
India
|
-
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47588
|
Lamivudine + Tenofovir disoproxil fumarate
|
Tenvir-L
|
300 mg/300 mg
|
Film Coated Tablet
|
-
|
Cipla Limited
|
India
|
-
|
07 December 2021
|
07 December 2024
|