| View |
|
DRP-14741
|
Clopidogrel (as bisulfate)
|
None
|
75 mg
|
Film-Coated Tablet
|
-
|
Akums Drugs & Pharmaceuticals Ltd. (Plant I - Solid
Oral Dosage Facility)
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
BR-1459
|
Tremelimumab
|
Imjudo
|
25 mg/1.25 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
20 December 2023
|
20 December 2028
|
| View |
|
BR-1458
|
Tremelimumab
|
Imjudo
|
300 mg/15 mL (20 mg/mL)
|
Concentrate for Solution for
Infusion (IV)
|
-
|
Vetter Pharma-Fertigung GmbH & Co. KG
|
Germany
|
Monitored Release
|
20 December 2023
|
20 December 2028
|
| View |
|
DR-XY48947
|
Gliclazide
|
Diakon MR
|
60 mg
|
Modified-Release Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14739
|
Quetiapine (as fumarate)
|
Nervas
|
100 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14738
|
Quetiapine (as fumarate)
|
Nervas
|
200 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-14742
|
Norepinephrine (as bitartrate)
|
Norfine
|
1 mg/mL (4 mg/4 mL)
|
Solution for Injection (IM/IV)
|
-
|
Kwality Pharmaceuticals Ltd.
|
India
|
Initial
|
20 December 2023
|
20 December 2028
|
| View |
|
DRP-9841
|
Folic Acid
|
Folidaze
|
5 mg
|
Capsule
|
-
|
Kanion Pharmaceutical Co., Ltd.
|
China
|
Initial (OTC)(PCPR)
|
23 June 2021
|
23 June 2026
|
| View |
|
DR-XY47089
|
Addaven
|
Minerals
|
(See reverse of CPR)
|
Concentrate Solution For IV Infusion
|
-
|
Fresenius Kabi Norge AS
|
Norway
|
Initial (Variation)
|
17 January 2023
|
26 February 2026
|
| View |
|
DRP-12583-02
|
Omeprazole (as Sodium)
|
Blueprazole
|
40 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
Proton Pump Inhibitor
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
CLIDP Conversion
|
28 November 2022
|
08 September 2027
|
| View |
|
DRP-9136-03
|
Paracetamol
|
Fevergo
|
150 mg/mL (300mg/2mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
CLIDP Conversion
|
10 April 2023
|
11 September 2025
|
| View |
|
DRP-9136-04
|
Paracetamol
|
MD-Zetamol
|
150 mg/mL (300 mg/2 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Furen Pharmaceutical Group Co., Ltd
|
China
|
CLIDP Conversion
|
04 May 2024
|
11 September 2025
|
| View |
|
DRP-8749-02
|
Clindamycin (as Phosphate)
|
Marzyn 600
|
150 mg/ mL (600 mg/4 mL)
|
Solution for Injection (I.M./I.V.)
|
Antibacterial (Lincosamide)
|
Vesco Pharmaceutical Company Limited
|
Thailand
|
Renewal
|
09 November 2024
|
21 February 2030
|
| View |
|
DRP-10761-01
|
Clindamycin (as phosphate)
|
Klindarone
|
150 mg/mL (300 mg/2 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Furen Pharmaceutical Group Co., Ltd
|
China
|
CLIDP Conversion
|
20 February 2023
|
16 November 2026
|
| View |
|
DRP-9144-01
|
Ceftriaxone (as sodium)
|
Zeptriavee
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
NCPC Hebei Huamin Pharmaceutical Company Limited
|
China
|
CLIDP Conversion
|
26 April 2023
|
03 November 2025
|
| View |
|
DRP-10961-03
|
Ceftriaxone (as Sodium)
|
Lourceft
|
1 g
|
Powder for Injection (I.M./I.V.)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
CLIDP Conversion
|
22 March 2023
|
22 December 2026
|
| View |
|
DRP-10961-04
|
Ceftriaxone (as sodium)
|
Bluecorecef
|
1 g
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Third-generation Cephalosporin)
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
CLIDP Conversion
|
04 January 2024
|
22 December 2026
|
| View |
|
DRP-11988-1
|
Ampicillin (as sodium)
|
Ronzillin 500
|
500mg
|
Powder for Injection (I.M./I.V.)
|
Antibacterial (Penicillin)
|
North China Pharmaceutical Co., Ltd
|
China
|
CLIDP Conversion
|
23 August 2023
|
27 May 2027
|
| View |
|
DRP-11801-03
|
Cefuroxime (as Sodium)
|
Lourxime
|
750 mg
|
Powder for Injection (I.M./I.V.)
|
-
|
Furen Pharmaceutical Group Co., Ltd.
|
China
|
CLIDP Conversion
|
01 August 2023
|
29 April 2027
|
| View |
|
DRP-13194-01
|
Ondansetron (as hydrochloride dihydrate)
|
Vomistop
|
2 mg / mL
|
Solution for Injection (I.V/I.M.)
|
-
|
PT. Novell Pharmaceutical Laboratories
|
Indonesia
|
CLIDP Conversion
|
19 July 2023
|
22 December 2027
|