| View |
|
DRP-12538
|
Omeprazole Sodium
|
Mepracid
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12552
|
Oxytocin
|
Fetusin
|
10 IU/mL
|
Solution for Injection (I.M./I.V.)
|
Oxytocic (Uterine Stimulant)
|
Sterile-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
|
DRP-12493
|
Clobetasol Propionate
|
Khrizvate
|
15mg per 30g (0.05% w/w)
|
Topical Cream
|
Anti-Inflammatory/Antipruritic
|
Merit Organics Ltd.
|
India
|
Initial [OTC] [PCPR]
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12539
|
Epirubicin (as hydrochloride)
|
Sanzepir-10
|
10 mg
|
Lyophilized Powder for Injection (IV)
|
Antineoplastic Agent
|
Admac Lifesciences
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12560
|
Ceftazidime
|
Gozidime
|
1g
|
Powder For Injection (IM/IV)
|
Antibacterial
|
Yeluri Formulations Pvt. Ltd.
|
India
|
Initial [Rx]
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12533
|
Azithromycin (as dihydrate)
|
Azimed
|
500 mg
|
Film-Coated Tablet
|
Antibacterial (Macrolide)
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12528
|
Celecoxib
|
Celenova
|
200 mg
|
Capsule
|
Non-Steroidal Anti-Inflammatory Drug (NSAID)
|
Ratnamani Healthcare Pvt. Ltd.
|
India
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
FDA-0586105
|
Azithromycin(As Dihydrate)
|
Novazith
|
500 mg
|
Film Coated Tablet
|
Antibacterial (Macrolide)
|
AMN Life Pvt. Ltd.
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12522
|
Levobupivacaine (as hydrochloride)
|
L-ascain
|
5 mg/mL
|
Solution for Injection
|
Anesthetic
|
PT. Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12561
|
Meformin Hydrochloride
|
Metromin
|
500mg
|
Film Coated Tablet
|
Oral hypoglycemic Agent (Biguanide)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12562
|
Meformin Hydrochloride
|
Metromin
|
1 g
|
Film Coated Tablet
|
Oral hypoglycemic Agent (Biguanide
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
02 September 2022
|
02 September 2027
|
| View |
DR-XY48341_PI_01.pdf
|
DR-XY48341
|
Pretomanid
|
Dovprela
|
200 mg
|
Tablet
|
Antimycobacterial
|
Mylan Laboratories Limited
|
India
|
Monitored Release (MR)
|
06 September 2022
|
06 September 2027
|
| View |
|
DRP-12555
|
Ketorolac Trometamol
|
Ketovex-30
|
30mg/mL
|
Solution For Injection (IV/IM)
|
-
|
Pharmavision San. ve Tic. A.S.
|
Turkey
|
Initial
|
01 September 2022
|
01 September 2027
|
| View |
|
DRP-12532
|
Losartan Potassium
|
Saphlor-50
|
50 mg
|
Film-Coated Tablet
|
Angiotensin II receptor Blockers
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12531
|
Losartan Potassium
|
Saphlor-100
|
100 mg
|
Film-Coated Tablet
|
Angiotensin II Receptor Blocker
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
02 September 2022
|
02 September 2027
|
| View |
DR-XY48318_PI_01.pdf
|
DR-XY48318
|
Lamivudine
|
Heptavir Os
|
10 mg/mL
|
Oral Solution
|
Antiviral (Nucleoside/Nucleotide Reverse
Transcriptase Inhibitor)
|
Hetero Labs Limited (Unit III)
|
India
|
Monitored Release
|
26 August 2022
|
26 August 2025
|
| View |
|
DRP-12540
|
Meropenem (As Trihydrate)
|
One-Mero 500
|
500 mg
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
Brooks Laboratories Limited
|
India
|
Initial (Reconstruction)
|
06 February 2024
|
30 August 2027
|
| View |
|
DRP-12537
|
Meropenem (as trihydrate)
|
One-Mero 1000
|
1 g
|
Powder for Injection (IV)
|
Antibacterial (Carbapenem)
|
Brooks Steriscience Limited
|
India
|
Initial (Reconstruction)
|
29 May 2024
|
31 August 2027
|
| View |
|
DRP-12523
|
Ceftriaxone (as sodium)
|
Baczone
|
1g
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-Generation Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
Initial
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12546
|
Fingolimod
|
None
|
500mcg
|
Capsule
|
Immunosuppressant
|
Aizant Drug Research Solutions Pvt. Ltd.
|
india
|
Initial
|
31 August 2022
|
31 August 2025
|