| View |
|
DRP-14836
|
Cloxacillin (as sodium)
|
None
|
500 mg
|
Capsule
|
-
|
Medico Remedies Limited
|
India
|
Initial (Re-application)
|
18 January 2024
|
18 January 2029
|
| View |
|
DRP-14831
|
Ibuprofen
|
Ibuglob-400
|
400mg
|
Film Coated Tablets
|
-
|
Globela Pharma Private Limited.
|
India
|
Initial (OTC)
|
18 January 2024
|
18 January 2029
|
| View |
|
DRP-14837
|
Telmisartan
|
ARB
|
40 mg
|
Film-Coated Tablet
|
-
|
Corona Remedies Pvt. Ltd.
|
India
|
Initial
|
19 January 2024
|
19 January 2029
|
| View |
|
DR-XY48980
|
Meropenem (as trihydrate)
|
None
|
500mgl
|
Powder for I.V Injection
|
-
|
Anfarm Hellas S.A
|
Greece
|
Initial
|
19 January 2024
|
19 January 2029
|
| View |
|
DR-XY48897
|
Febuxostat
|
Atenurix
|
80mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
05 October 2023
|
28 June 2027
|
| View |
|
DR-XY48896
|
Febuxostat
|
Atenurix
|
40 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Initial (Correction)
|
05 October 2023
|
28 June 2027
|
| View |
|
DRP-11492-03
|
Omeprazole (as sodium)
|
Jaczole
|
40 mg
|
Lyophilized Powder for Injection (IV Infusion)
|
-
|
Jodas Expoim Pvt. Ltd
|
India
|
CLIDP Conversion
|
19 February 2023
|
17 March 2027
|
| View |
|
DRP-11728-04
|
Co-Amoxiclav
|
Rifeclav
|
625 mg
|
Film-Coated Tablet
|
-
|
Giyaan Pharma Pvt. Ltd
|
India
|
CLIDP Conversion
|
25 October 2022
|
29 October 2026
|
| View |
|
DRHR-2326
|
Isopropyl Alcohol
|
None
|
70 mL (70% v/v) per 100 mL
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRHR-2325
|
Isopropyl Alcohol
|
None
|
70 mL (70% v/v) per 100 mL
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14843
|
Paracetamol
|
None
|
500 mg
|
Tablet
|
-
|
Wintech Pharmaceuticals Limited
|
India
|
Initial [OTC]
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14839
|
Clopidogrel (as bisulfate)
|
ClopidoMed
|
75mg
|
Film Coated Tablet
|
-
|
Rhydburg Pharmaceuticals Limited.
|
India
|
Initial
|
22 January 2024
|
22 January 2029
|
| View |
|
DR-XY48982
|
Eicosapentaenoic acid (EPA) Ethyl Docosahexaenoic acid (DHA) Ethyl Ester
|
Romega
|
465 mg/375 mg
|
Softgel Capsule
|
-
|
Humanwell Puracap Pharmaceuticals (Wuhan) Co.,
Ltd.
|
China
|
Monitored Release (MR)
|
19 January 2024
|
19 January 2029
|
| View |
|
DRP-14848
|
Ascorbic Acid + Cholecalciferol + Zinc
|
Tri-O-Vit
|
500 mg (equivalent to 562.4 mg Sodium Ascorbate)/ 400 IU/ 20 mg (equivalent to 55 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Diamond Laboratories, Inc.
|
Philippines
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14838
|
Lidocaine Hydrochloride (as monohydrate)
|
Puriecaine
|
20 mg/mL (2%)
|
Solution For Injection
|
-
|
Makcur Laboratories Limited
|
India
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRHR-2327
|
Isopropyl Alcohol
|
Alco 70
|
70 mL (70% v/v) per 100 mL
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
DRHR-2328
|
Isopropyl Alcohol
|
Alco 70
|
70 mL (70% v/v) per 100 mL
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
DRHR-2329
|
Isopropyl Alcohol
|
Alco 70
|
70 mL (70% v/v) per 100 mL
|
Solution
|
-
|
Greenstone Pharmaceutical, Inc.
|
Philippines
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
DRP-14840
|
Linagliptin + Metformin Hydrochloride
|
Myglip Plus 2.5/500
|
2.5 mg/ 500 mg
|
Film-Coated Tablet
|
-
|
Alidac Healthcare (Myanmar) Ltd.
|
Myanmar
|
Initial (Reapplication)
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14841
|
Linagliptin + Metformin Hydrochloride
|
Myglip Plus 2.5/850
|
2.5 mg/ 850 mg
|
Film-Coated Tablet
|
-
|
Alidac Healthcare (Myanmar) Ltd.
|
Myanmar
|
Initial (Reapplication)
|
23 January 2024
|
23 January 2029
|