| View |
|
DRP-12321
|
Amlodipine (as besilate)
|
Neldipin
|
5mg
|
Tablet
|
Calcium Channel Blocker
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DR-XY48154
|
Sevelamer Carbonate
|
Lophos
|
800mg
|
Film-Coated Tablet
|
Hypophosphatemic Agent
|
Pharmathen International SA
|
Greece
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12224
|
Co-Amoxiclav
|
None
|
228.5 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin and Beta-Lactamase Inhibitor)
|
Sparsh Bio-Tech Pvt., Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12270
|
Montelukast (as Sodium)
|
Kastair
|
4 mg
|
Oral Granules
|
-
|
Bilim Ilac San. Ve Tic. A.Ş.
|
Turkey
|
Initial
|
11 July 2022
|
11 July 2027
|
| View |
|
DR-XY48178
|
Metformin Hydrochloride + Gliclazide
|
Glyzeric
|
500 mg/80 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
11 July 2022
|
11 July 2027
|
| View |
|
DRP-12247
|
Bendamustine Hydrochloride (as monohydrate)
|
Fonkomustin
|
100 mg
|
Lyophilized Powder For Injection (IV)
|
Antineoplastic (Nitrogen Mustard Analogue)
|
PT. Fonko International Pharmaceuticals
|
Indonesia
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12236
|
Fludarabine (as phosphate)
|
Fludaraccord
|
25mg/mL(50mg/ 2mL)
|
Solution for Injection (IM/IV)
|
-
|
Intas Pharmaceuticals Limited
|
India
|
Monitored Release
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12244
|
Co-Amoxiclav
|
Elmox-CV 625
|
625mg
|
Film-Coated Tablet
|
-
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DRP-12243
|
Co-Amoxiclav
|
Elmox-CV 228.5
|
228.5mg/5mL
|
Powder for Oral Suspension
|
Antibacterial (Penicillin)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48131
|
Ceftazidime (As Pentahydrate)
|
Ceftadime
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation cephalosporin)
|
Scott-Edil Advance Research Laboratories & Education Limited
|
India
|
Initial
|
01 July 2022
|
01 July 2027
|
| View |
|
DR-XY48187
|
Bisoprolol Fumarate
|
Bisocor
|
5 mg
|
Tablet
|
Beta blocking agents, Selective
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial (correction)
|
30 September 2022
|
13 July 2027
|
| View |
|
DR-XY48177
|
Bisoprolol Fumarate
|
Bisocor
|
2.5 mg
|
Tablet
|
Beta blocking agents, Selective
|
Y.S.P. Industries (M) Sdn. Bhd.
|
Malaysia
|
Initial
|
11 July 2022
|
11 July 2027
|
| View |
|
DRP-12225
|
Atorvastatin (As Calcium Trihydrate)
|
Atormed-10
|
10mg
|
Film Coated Tablet
|
-
|
ACME Formulations Pvt. Ltd.
|
India
|
Initial
|
12 July 2022
|
12 July 2027
|
| View |
DR-XY48190_PI_01.pdf
|
DR-XY48190
|
Atazanavir (As Sulfate)
|
Atavir 300
|
300mg
|
Capsule
|
-
|
Hetero Labs Limited
|
India
|
Monitored Release
|
14 July 2022
|
14 July 2027
|
| View |
DR-XY48192_PI_01.pdf
|
DR-XY48192
|
Atazanavir (As Sulfate)
|
Atavir 150
|
150mg
|
Capsule
|
-
|
Hetero Labs Limited
|
India
|
Monitored Release
|
14 July 2022
|
14 July 2027
|
| View |
|
DR-XY48189
|
Amlodipine(As Besilate)
|
Amlovac
|
5mg
|
Tablet
|
Calcium Channel Blocker
|
Celogen Generics Private Ltd.
|
India
|
Initial
|
13 July 2022
|
13 July 2027
|
| View |
|
DR-XY48149
|
Amino Acids
|
Aminoven
|
0.1
|
Solution for IV Infusion
|
Parenteral Nutrition
|
Fresenius Kabi Austria GmbH
|
Austria
|
Initial (correction)
|
09 February 2023
|
30 June 2027
|
| View |
DR-XY48150_PI_01.pdf
|
DR-XY48150
|
Abiraterone Acetate
|
Abirone
|
250 mg
|
Tablet
|
-
|
Aziant Drug Research Solutions Pvt. Ltd.
|
India
|
Initial
|
30 June 2022
|
30 June 2027
|
| View |
|
DRP-12252
|
Ampicillin (As Sodium) + Sulbactam (As Sodium)
|
Sulpi-750
|
500mg/250mg
|
Powder For Injection (IV/IM)
|
Antibacterial (Combination of Penicillins including Beta-Lactamase Inhibitor)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
04 July 2022
|
04 July 2027
|
| View |
|
DRP-12219
|
Montelukast (as sodium) + Levocetirizine Hydrochloride
|
Zykids Forte
|
5 mg/ 5 mg
|
Chewable Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial
|
21 July 2022
|
06 July 2027
|