| View |
|
DRP-10953-02
|
Dorzolamide (as hydrochloride) + Timolol (as maleate)
|
Dorlaz T
|
20 mg/5 mg per mL (2.0%/0.5% w/v)
|
Sterile Ophthalmic Solution (Eye Drops)
|
Antiglaucoma/Miotic
|
Alwin DMD Pharmaceuticals
|
India
|
CLIDP Conversion
|
17 May 2024
|
22 December 2026
|
| View |
|
DRP-11095-03
|
Sevoflurane
|
Florex
|
100% v/v
|
Volatile Liquid for Inhalation
|
General Anesthetic
|
Hana Pharmaceutical Co., Ltd.
|
Korea
|
CLIDP Conversion
|
16 May 2024
|
28 January 2027
|
| View |
|
DRP-12424-02
|
Omeprazole (as sodium monohydrate)
|
Acetor
|
40 mg
|
Lyophilized Powder for Injection (IV)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
13 May 2023
|
04 August 2027
|
| View |
|
DRP-12424-01
|
Omeprazole (as sodium monohydrate)
|
Prazotam
|
40mg
|
Lyophilized Powder for Injection (I.V.)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
27 April 2023
|
04 August 2027
|
| View |
|
DRP-10440-03
|
Ceftriaxone (as sodium)
|
Ceftrisave
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
NCPC Hebei Huamin Pharmaceutical Company
|
China
|
CLIDP Conversion
|
02 November 2023
|
08 October 2026
|
| View |
|
DRP-10088-06
|
Nicardipine Hydrochloride
|
Gocardi
|
1 mg / mL
|
Solution for IV Infusion
|
Calcium Channel Blocker
|
Furen Pharmaceutical Group Co., Ltd
|
China
|
CLIDP Conversion
|
09 July 2023
|
15 May 2025
|
| View |
|
DRP-11250-03
|
Cefuroxime (as sodium)
|
None
|
750 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Cephalosporin)
|
Swiss Parenterals Ltd
|
India
|
CLIDP Conversion
|
11 May 2023
|
17 February 2027
|
| View |
|
DR-XY48859
|
Beclometasone diproprionate + dihydrate Glycopyrronium bromide.
|
Trimbow
|
200 mcg/ 6 mcg/ 12.5 mcg per actuation
|
Metered Dose Inhaler
|
Adrenergic-Corticosteroid-Anticholinergic Combination
|
Chiesi Farmaceutici S.p.A.
|
Italy
|
Monitored Release
|
24 August 2023
|
24 August 2028
|
| View |
|
DR-XY47830
|
Testosterone
|
Natesto
|
5.5 mg per actuation (4.5% w/w)
|
Nasal Gel
|
Androgen (3-oxoandrosten (4) derivative]
|
Haupt Pharma Amareg GmbH
|
Germany
|
Monitored Release
|
30 March 2022
|
30 March 2025
|
| View |
|
DRP-9190
|
Olanzapine
|
None
|
10 mg
|
Orodispersible tablet
|
Antipsychotic
|
Aurobindo Pharma Limited
|
India
|
Initial
|
01 October 2020
|
01 October 2025
|
| View |
|
DR-XY49083
|
Atogepant
|
Aquipta
|
10 mg
|
Tablet
|
Antimigraine Preparation [Calcitonin Gene-Related
Peptide (CGRP) Antagonist]
|
AbbVie S.r.I.
|
Italy
|
Monitored Release (FRP Abridged Review)
|
16 May 2024
|
16 May 2029
|
| View |
|
DR-XY49084
|
Atogepant
|
Aquipta
|
60 mg
|
Tablet
|
Antimigraine Preparation [Calcitonin Gene-Related
Peptide (CGRP) Antagonist]
|
AbbVie S.r.I.
|
Italy
|
Monitored Release (FRP Abridged Review)
|
16 May 2024
|
16 May 2029
|
| View |
|
DRP-15157
|
Cefoxitin (as sodium)
|
None
|
1 g
|
Powder for Injection (IM/IV)
|
Antibacterial (Second-generation Cephalosporin)
|
Swiss Parenterals Ltd.
|
India
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DRP-15140
|
Rosuvastatin (as calcium) + Fenofibrate
|
Fenrus
|
20 mg/160 mg
|
Film-Coated Tablet
|
Lipid Modifying Agents
|
Mediwin Pharmaceuticals
|
India
|
Initial
|
14 May 2024
|
14 May 2029
|
| View |
|
DRP-15159
|
Ceftazidime (as pentahydrate) with sodium carbonate
|
Luozidime
|
1 g
|
Powder for Solution for IV Infusion
|
Antibacterial (Third-generation Cephalosporin)
|
Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.
|
China
|
Initial
|
16 May 2024
|
16 May 2029
|
| View |
|
DRP-15155
|
Fluconazole
|
Desfluzole 200
|
200 mg
|
Capsule
|
Antifungal (Triazole derivative)
|
Lincoln Pharmaceuticals Ltd.
|
IndIa
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DRP-15146
|
Cefoperazone (as sodium) + Sulbactam (as sodium)
|
Kephazon-S
q
|
500 mg/500 mg
|
Powder for Injection (IM/IV)
|
Antibacterial (Third-generation Cephalosporin)
|
United Biotech Pvt. Ltd.
|
India
|
Initial
|
16 May 2024
|
16 May 2029
|
| View |
|
DR-XY49081
|
Esomeprazole (as sodium)
|
None
|
40 mg
|
Lyophilized Powder for I.V. Injection.
|
Proton pump inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DR-XY49080
|
Febuxostat
|
Febtout 80
|
80 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Adnova Healthcare Pvt. Ltd.
|
India
|
Initial
|
15 May 2024
|
15 May 2029
|
| View |
|
DRP-15154
|
Levofloxacin (as hemihydrate)
|
Aploxin
|
500 mg
|
Film-Coated Tablet
|
Antiinfective (Fluoroquinolone)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
15 May 2024
|
15 May 2029
|