| View |
|
DR-XY47586
|
Atazanavir (as sulfate) + Ritonavir
|
Synthivan
|
300 mg/100 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Cipla Limited
|
India
|
Monitored Release
|
07 December 2021
|
07 December 2024
|
| View |
|
DR-XY47587
|
Atazanavir (as sulfate) + Ritonavir
|
Synthivan
|
300 mg/100 mg
|
Film Coated Tablet
|
Antiviral Combination
|
Cipla Limited
|
India
|
Monitored Release
|
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
|
| 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-XY4759
|
Inosiplex
|
Immunosin
|
500 mg
|
Tablet
|
Direct Acting Antiviral
|
Amherst Laboratories, Inc.
|
Philippines
|
Automatic Renewal
|
22 October 2022
|
05 November 2027
|
| View |
|
DR-XY47590
|
Pantoprazole (as sodium sesquihydrate)
|
Panvell
|
40 mg
|
Enteric-Coated Tablet
|
Proton Pump Inhibitor
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
Initial
|
09 December 2021
|
09 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 |
|
DR-XY47592
|
Cefuroxime (as axetil)
|
Zegen
|
250mg
|
Film-Coated Tablet
|
Antibacterial (Cephalosporin)
|
P.T. Darya Varia Laboratories Tbk
|
Indonesia
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47593
|
Budesonide
|
None
|
250 mcg/mL (500 mcg/
2mL)
|
Suspension for Nebulization
|
Glucocorticoid
|
Cipla Ltd. (Unit I)
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47594
|
Tretinoin
|
Tretinon
|
500 mcg/g (0.05% w/w)
|
Topical Cream
|
Anti-acne
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (OTC) [Correction]
|
21 January 2022
|
09 December 2026
|
| View |
|
DR-XY47595
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Unacilyn
|
1 g/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Penicillin/Beta-lactamase inhibitor)
|
Karnataka Antibiotics & Pharma Ltd.
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47596
|
Latanoprost
|
Xalaprost
|
50 mcg/mL (0.005% w/v)
|
Ophthalmic Solution (Drops)
|
-
|
Beximco Pharmaceuticals Ltd.
|
Bangladesh
|
-
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47597
|
Ampicillin (as sodium) + Sulbactam (as sodium)
|
Asulbac
|
1g/ 500mg
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Penicillin-Beta-lactamase Inhibitor
Combination)
|
Akums Drugs & Pharmaceuticals Ltd.
|
India
|
Initial
|
09 December 2021
|
09 December 2026
|
| View |
|
DR-XY47598
|
Sertaconazole nitrate
|
Zalain
|
20 mg/g (2% w/w)
|
Topical Cream
|
Antifungal (Imidazole/Triazole Derivative)
|
Ferrer Internacional, S.A.
|
Spain
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
DR-XY47600_PI_01.pdf
|
DR-XY47600
|
Doxofylline
|
Maxivent
|
400 mg
|
Tablet
|
Bronchodilator
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY47602
|
Rosuvastatin (as calcium) + Clopidogrel (as bisulfate)
|
Turbovas-CP
|
5 mg/75 mg
|
Capsule*
[*Rosuvastatin film-coated tablet enclosed in a hard
gelatin capsule with the Clopidogrel powder blend]
|
Lipid Modifying Agent-Antithrombotic Agent
Combination
|
Micro Labs Limited
|
India
|
Monitored Release
|
10 December 2021
|
10 December 2026
|
| View |
|
DR-XY47604
|
Calcium folinate (as Folinic acid)
|
None
|
10 mg/mL
|
Solution for Injection/Infusion (I.M./I.V.)
|
Detoxifying Agent for Antineoplastic Treatment
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial
|
13 December 2021
|
13 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 |
|
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-XY47607
|
Pemetrexed (as disodium)
|
Pemexed 500
|
500 mg
|
Lyophilized Powder for IV Infusion
|
-
|
Gland Pharma Limited
|
India
|
-
|
14 December 2021
|
14 December 2026
|