| View |
|
DRP-11951
|
Co-Amoxiclav
|
Genclav
|
156.25mg/5ml
|
Powder for Suspension
|
Antibacterial (Penicillin/ Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-11950
|
Co-Amoxiclav
|
Genclav
|
312.5mg/5mL
|
Powder for Suspension
|
Antibacterial (Penicillin/ Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
23 May 2022
|
23 May 2027
|
| View |
|
DRP-11949
|
Co-Amoxiclav
|
Genclav
|
457mg/5mL
|
Powder for Suspension
|
Antibacterial (Penicillin/Beta-lactamase Inhibitor)
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DRP-11938
|
Cefepime (As Hydrochloride)
|
Globalpime
|
1.0 g
|
Powder for Injection (I.V./I.M.)
|
Antibacterial (Cephalosporin)
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
20 May 2022
|
20 May 2027
|
| View |
|
DRP-12009
|
Tranexamic Acid.
|
Tranhil
|
100 mg/mL (500 mg/5 mL)
|
Solution for Injection (I.M./I.V.)
|
Antifibrinolytic
|
Makcur Laboratories Limited.
|
India
|
Initial (Variation-turned-Initial)
|
24 September 2024
|
24 September 2029
|
| View |
|
DRP-11991
|
Losartan potassium + Hydrochlorothiazide +
Amlodipine (as besilate)
|
Amlozaar H
|
50 mg/12.5 mg/5 mg
|
Film Coated Tablet
|
Antihypertensive [Angiotensin II Receptor Blocker
(ARB), Diuretic and Calcium Channel Blocker
Combination]
|
Micro Labs Limited
|
India
|
Initial from Monitored Release]
|
26 May 2022
|
07 April 2025
|
| View |
|
DR-XY 48038
|
Linagliptin + Metformin Hyydrochloride
|
Trajenta Duo
|
2.5mg/500mg
|
Film-Coated Tablet
|
Oral Blood Glucose Lowering Drug Combination
|
Boehringer Ingelheim Promeco, S.A. de C.V.
|
Mexico
|
Initial
|
25 May 2022
|
25 May 2027
|
| View |
|
DRP-11988
|
Ampicillin (as sodium)
|
Giocillin
|
500mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin)
|
North China Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DRP-11987
|
Ampicillin (as sodium)
|
Giocillin
|
1g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin)
|
North China Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 May 2022
|
27 May 2027
|
| View |
|
DR-XY48059
|
Pemetrexed
|
Pemexbil
|
500 mg
|
Lyophilized Powder for Intravenous (I.V.) Infusion
|
Antineoplastic (Folic Acid Analogue)
|
SP Accure Labs Pvt. Ltd.
|
India
|
Initial
|
30 May 2022
|
30 May 2027
|
| View |
|
DR-XY48064
|
Atorvastatin (as Calcium) + Fenofibrate
|
Fenostat
|
10mg/160mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release)
|
30 May 2022
|
16 March 2025
|
| View |
|
DR-XY48063
|
Atorvastatin (as Calcium) + Fenofibrate
|
Fenostat
|
20 mg/ 160mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (from Monitored Release)
|
30 May 2022
|
16 March 2025
|
| View |
|
DR-XY48065
|
Febuxostat
|
Atenurix
|
20 mg
|
Film-Coated Tablet
|
Antigout preparation
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
24 September 2024
|
16 March 2025
|
| View |
|
DRP-8514
|
Clopidogrel (As Bisulfate)
|
Corplet
|
75 mg
|
Film coated tablet
|
Antithrombotic Agent(Platelet Aggregation Inhibitor)
|
Mepro Pharmaceuticals Pvt. Ltd.
|
India
|
Automatic Renewal (Variation: PCPR Conversion)(Reconstruction)
|
08 April 2022
|
22 November 2027
|
| View |
|
DRP-11989
|
Meclizine Hydrochloride
|
Ramec
|
12.5 mg
|
Chewable Tablet
|
Anti-Emetic/ Antivertigo
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC)
|
26 May 2022
|
26 May 2027
|
| View |
|
DRP-12066
|
Levodropropizine
|
Levare
|
60 mg
|
Tablet
|
Cough Suppressant
|
Sinil Pharmaceutical Co., Ltd.
|
Korea
|
Monitored Release
|
16 June 2022
|
16 June 2027
|
| View |
|
DRP-12043
|
Abiraterone Acetate
|
Abiron
|
250 mg
|
Tablet
|
Antineoplastic/Immunomodulating Agent (Hormone Antagonist/Related Agent)
|
BDR Pharmaceuticals International Pvt. Ltd. -
Oncology Unit
|
India
|
Initial
|
02 June 2022
|
02 June 2027
|
| View |
|
DR-XY48073
|
Azacitidine
|
Xpreza
|
100mg
|
Lyophilized Powder for Injection (I.V./S.C.)
|
Antineoplastic (Pyrimidine Analogue)
|
Natco Pharma Limited
|
India
|
Monitored Release (Reconstruction)
|
11 November 2022
|
31 May 2027
|
| View |
|
DRP-12024
|
Citicoline (As sodium)
|
Pharcholine
|
500 mg
|
Tablet
|
Psychostimulant and Nootropic
|
Magbro Healthcare Pvt., Ltd.
|
India
|
Initial
|
07 June 2022
|
07 June 2027
|
| View |
|
DRP-12104
|
Diclofenac (as sodium)
|
Diclophil
|
25mg/mL (75mg/3mL)
|
Solution for Injection
(I.M./I.V.)
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
Initial
|
13 June 2022
|
13 June 2027
|