| View |
|
DR-XY47863
|
Ceftazidime (as pentahydrate)
|
Fotaran
|
1 g
|
Powder for Injection (IV/IM)
|
-
|
VHB Medi Sciences Limited
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47866
|
Febuxostat
|
Fegout
|
80 mg
|
Film-Coated Tablet
|
-
|
Korea United Pharm. Inc.
|
Korea
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47868
|
Rivaroxaban
|
Rivaban
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic agents (direct factor Xa inhibitor)
|
Lupin Limited (Unit II)
|
India
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47870
|
Acalabrutinib
|
Calquence
|
100 mg
|
Capsule
|
Antineoplastic agent (Protein Kinase Inhibitor)
|
AstraZeneca AB
|
Sweden
|
Monitored Release
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47872
|
Fluconazole
|
Flukal
|
200mg in 100mL (2mg/mL)
|
Solution for Intravenous Infusion
|
Antimycotics for systematic use (triazole and Tetrazole Derivative
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47873
|
Fluconazole
|
Axa-Zole F
|
2mg/mL (200 mg/100 mL)
|
Solution for Intravenous Infusion
|
Antimycotics for systematic use (triazole and Tetrazole Derivative
|
Axa Parenterals Limited
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47874
|
Omeprazole (as sodium)
|
None
|
40 mg
|
Lyophilized Powder for I.V. Injection
|
Proton Pump Inhibitor
|
Steril-Gene Life Sciences Pvt. Ltd.
|
India
|
Initial (Re-application)
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47875
|
Pregabalin
|
Neurokem
|
150 mg
|
Capsule
|
-
|
Alkem Laboratories Ltd.
|
India
|
-
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47876
|
Solifenacin Succinate
|
Urgiso
|
10 mg
|
Film-Coated Tablet
|
Selective M3 Antimuscarinic Receptor Antagonist
|
Micro Labs Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
|
DR-XY47877
|
Solifenacin Succinate
|
Urgiso
|
5 mg
|
Film-Coated Tablet
|
Selective M3 Antimuscarinic Receptor Antagonist
|
Micro Labs Limited
|
India
|
Initial
|
01 April 2022
|
01 April 2027
|
| View |
|
DR-XY47878
|
Montelukast Sodium + Cetirizine Hydrochloride
|
Alduet
|
10mg/10mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
-
|
01 April 2022
|
01 April 2027
|
| View |
DR-XY47879_PI_01.pdf
|
DR-XY47879
|
Bendamustine hydrochloride (as monohydrate)
|
Bentero 100
|
100 mg
|
Lyophilized Powder for Injection for I.V.
Infusion
|
-
|
Hetero Labs Limited (Unit-VI, TSIIC, Formulation
SEZ)
|
India
|
-
|
31 March 2022
|
31 March 2025
|
| View |
|
DR-XY47881
|
Metoprolol tartrate
|
M-Card
|
1 mg/mL
|
Solution for I.V. Injection
|
Beta Blocker
|
Baxter Pharmaceuticals India Private Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47882
|
Remdesivir
|
Desrem
|
100 mg
|
Lyophilized Powder for Solution for I.V.
Infusion
|
Antiviral
|
Gland Pharma Limited
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
DR-XY47883_PI_01.pdf
|
DR-XY47883
|
Remdesivir
|
Desrem
|
100 mg
|
Lyophilized Powder for Solution for I.V.
Infusion
|
Antiviral
|
Mylan Laboratories Limited (Specialty Formulation
Facility)
|
India
|
Monitored Release
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47884
|
Biotin
|
None
|
5mg
|
Capsule
|
-
|
Solgar, Inc.
|
United States of America
|
Initial [OTCI
|
31 March 2022
|
31 March 2026
|
| View |
|
DR-XY47885
|
Cholecalciferol (Vitamin D3)
|
None
|
50mcg (2,000 IU)
|
Tablet (Strawberry Flavor)
|
-
|
Natrol LLC
|
United States of America
|
Initial (OTC)
|
31 March 2022
|
31 March 2026
|
| View |
|
DR-XY47886
|
Aripiprazole
|
Arpivex 10
|
10 mg
|
Orally Disintegrating Tablet
|
Antipsychotic
|
West Coast Pharmaceutical Works Ltd.
|
India
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
|
DR-XY47887
|
Pemetrexed (as disodium)
|
Cartrexed
|
100 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Antineoplastic Agent (Folic Acid Analogues)
|
Shanghai Chemo Wanbang Biopharma Co., Ltd.
|
China
|
Initial
|
31 March 2022
|
31 March 2027
|
| View |
DR-XY47888_PI_01.pdf
|
DR-XY47888
|
Olmesartan Medoxomil
|
Alzor
|
20 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
01 April 2022
|
01 April 2027
|