| View |
|
DRP-11660
|
Paracetamol
|
Paracerol
|
10 mg/mL (1 g/100 mL)
|
Solution for I.V. Infusion
|
Analgesic/Antipyretic (Anilide)
|
Aroma Ilac Sanayi Ltd. Sti.
|
Turkey
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DRP-11648
|
Paclitaxel
|
Paclidex
|
6 mg/mL (30 mg/5 mL; 100 mg/16.67 mL; 150 mg/25 mL; and 300 mg/50 mL)
|
Concentrated Solution for
Injection (I.V. Infusion)
|
Antineoplastic Agent (Taxane)
|
Laboratorio Varifarma S.A.
|
Argentina
|
Initial
|
06 April 2022
|
06 April 2027
|
| View |
|
DRP-11662
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Novac
|
1 g/500 mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
07 April 2022
|
07 April 2027
|
| View |
|
DRP-11515
|
Clopidogrel (as bisulfate)
|
None
|
75 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11622
|
Rosuvastatin (as calcium)
|
None
|
10 mg
|
Film-Coated Tablet
|
HMG COA Reductase Inhibitor
|
United International Pharma Co. Ltd.
|
Vietnam
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11621
|
Rosuvastatin (as calcium)
|
None
|
20 mg
|
Film-Coated Tablet
|
HMG-CoA Reductase Inhibitor
|
United International Pharma Co., Ltd.
|
Vietnam
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11468
|
Amlodipine (as Besilate) + Valsartan
|
Valazyd AM 5/160
|
5 mg/ 160 mg
|
Film Coated Tablet
|
Calcium Channel Blocker/
Angiotensin II Receptor Blocker (ARB)
|
Cadila Healthcare Limited
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11517
|
Clopidogrel (as bisulfate)
|
Noklot
|
75 mg
|
Film Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor)
|
Cadila Healthcare Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
|
DRP-11503
|
Montelukast (as sodium)
|
Montezen
|
10 mg
|
Film-Coated Tablet
|
Leukotriene receptor antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11498
|
Montelukast (as sodium)
|
Montesolv
|
10 mg
|
Film-Coated Tablet
|
Leukotriene receptor antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11504
|
Montelukast (as sodium)
|
Monteshield
|
10 mg
|
Film-Coated Tablet
|
Leukotriene receptor antagonist
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11499
|
Montelukast (as sodium)
|
Monteresp
|
10 mg
|
Film-Coated Tablet
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
-
|
08 April 2022
|
08 April 2027
|
| View |
|
DRP-11635
|
Amlodipine (As Besilate)
|
Medpin-5
|
5 mg
|
Tablet
|
Calcium Channel Blocker
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11636
|
Amlodipine (As Besilate)
|
Medpin-10
|
10 mg
|
Tablet
|
Calcium Channel Blocker
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11525
|
Levofloxacin
|
Levonova-500
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11639
|
Entecavir (as monohydrate)
|
Hepavir
|
500 mcg
|
Film-Coated Tablet
|
Antiviral
|
Genuone Sciences Inc.
|
Korea
|
Initial
|
05 April 2022
|
05 April 2027
|
| View |
DR-XY47898_PI_01.pdf
|
DR-XY47898
|
Gemcitabine(as hydrochloride)
|
Gemcilex
|
200 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic (Pyrimidine analogues)
|
Laboratorio Kemex S.A.
|
Argentine Republic
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11573
|
Cefuroxime (as sodium)
|
Furoxinova
|
750 mg
|
Powder for Injection (IV/IM)
|
Second Generation Cephalosporin
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DRP-11620
|
Febuxostat
|
Febumax
|
40 mg
|
Film Coated Tablet
|
Antigout
|
Gracure Pharmaceutical Ltd.
|
India
|
Initial
|
04 April 2022
|
04 April 2027
|
| View |
|
DRP-11647
|
Esomeprazole (As Sodium)
|
Esomekar
|
40 mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Sakar Healthcare Pvt. Ltd.
|
India
|
Initial
|
06 April 2022
|
06 April 2027
|