| View |
|
DRP-10751
|
Efavirenz + Lamivudine + Tenofovir disoproxil
fumarate
|
Tefami
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Laurus Labs Limited (Unit II)
|
India
|
Monitored Release
|
06 December 2021
|
06 December 2024
|
| View |
|
DR-XY47606
|
Losartan Potassium
|
Starlo
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Saga Laboratories
|
India
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
DR-XY47605
|
Losartan Potassium
|
Starlo
|
100 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker (ARB)
|
Saga Laboratories
|
India
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
FDA-0564821
|
Capecitabine
|
Pacsita 150
|
150 mg
|
Film-Coated Tablet
|
-
|
Eugia Pharma Specialties Limited Survey
|
India
|
-
|
01 December 2021
|
01 December 2026
|
| View |
|
DR-XY47591
|
Oxaliplatin
|
Oxaltin
|
5 mg/mL (50 mg/10 mL and 100 mg/20 mL)
|
Concentrate Solution for Intravenous Injection
|
Antineoplastic
|
Jiangsu Hengrui Medicine Co., Ltd.
|
China
|
Initial (correction)
|
28 December 2022
|
09 December 2026
|
| View |
|
DRP-10870
|
Mometasone Furoate
|
Novatasone
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
-
|
Blossom Pharmaceuticals
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DRP-10901
|
Vitamin B-Complex + Iron + Buclizine hydrochloride
|
None
|
Each capsule contains:
Thiamine mononitrate (Vitamin B1) Pyridoxine Hydrochloride (Vitamin B6) Cyanocobalamine (Vitamin B12) Ferrous fumarate (equivalent to Elemetal Iron 25 mg) Buclizine hydrochloride
10.00 mg 5.00 mg 10.00 mcg 76.00 mg
25.00 mg
|
Capsule
|
Appetite Stimulant
|
Am-Europharma Corporation
|
Philippines
|
Initial
|
14 December 2021
|
14 December 2026
|
| View |
|
DRP-10853
|
Amlodipine (as Besilate)
|
None
|
5 mg
|
Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10852
|
Amlodipine (as Besilate)
|
None
|
10 mg
|
Film-Coated Tablet
|
Antihypertensive (Calcium channel blocker)
|
Phil. United Pharma Corp.
|
Philippines
|
Initial
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10750
|
Efavirenz + Lamivudine + Tenofovir disoproxil
fumarate
|
None
|
600 mg/300 mg/300 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Laurus Labs Limited (Unit II)
|
India
|
Monitored Release
|
06 December 2021
|
06 December 2024
|
| View |
|
DRP-10880
|
Dicycloverine Hydrochloride
|
None
|
10 mg
|
Tablet
|
Anticholinergic
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
10 December 2021
|
10 December 2026
|
| View |
|
DRP-570-04
|
Omeprazole
|
None
|
20 mg
|
Capsule
|
Proton Pump Inhibitor
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
04 January 2023
|
07 December 2027
|
| View |
|
DR-XY44516
|
Cefixime (As Trihydrate)
|
None
|
200 mg
|
Capsule
|
Antibacterial (Cephalosporin)
|
Drugmaker's Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
29 March 2022
|
08 May 2027
|
| View |
|
HRP-487
|
Tretinoin + Hydroquinone
|
None
|
10mg/2g per 100 mL (0.01%/2% w/v)
|
Solution
|
Anti-Acne, Depigmenting Agent
|
Vonwelt Inc.
|
Philippines
|
Initial
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY43942
|
Gemcitabine (as hydrochloride)
|
Unbranded
|
38 mg/mL (1g/26.3 mL)
|
Solution For Intravenous Infusion
|
Antineoplastic
|
Zydus Hospira Oncology Pvt. Ltd.
|
India
|
Renewal
|
29 September 2024
|
05 December 2029
|
| View |
|
DR-XY43941
|
Gemcitabine (as hydrochloride)
|
Unbranded
|
38 mg/mL (200 mg/5.3mL)
|
Solution For Intravenous Injection
|
Antineoplastic
|
Zydus Hospira Oncology Pvt. Ltd.
|
India
|
Renewal
|
12 October 2024
|
05 December 2029
|
| View |
|
DRP-10849
|
Amlodipine (as Besilate)
|
Lorvasc
|
5 mg
|
Film-Coated tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10848
|
Amlodipine (as Besilate)
|
Lorvasc
|
10 mg
|
Tablet
|
-
|
Phil. United Pharma Corp.
|
Philippines
|
-
|
06 December 2021
|
06 December 2026
|
| View |
|
DRP-10821
|
Rosuvastatin (As Calcium)
|
Kingstat 10
|
5 mg
|
Film-Coated Tablet
|
HMG CoA Reductase Inhibitor
|
Sun Pharmaceutical Industries Limited.
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
03 December 2026
|
| View |
|
DRP-10822
|
Rosuvastatin (As Calcium)
|
Kingstat 40
|
40 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitors
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial (Reconstruction)
|
31 July 2024
|
03 December 2026
|