View |
|
DRP-14460
|
Clobetasol Propionate
|
Glevate
|
500 mcg/g (0.05% w/w)
|
Topical Ointment
|
-
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
07 September 2023
|
07 September 2028
|
View |
|
DR-XY48873
|
D-Alpha Tocopherol (Vitamin E)
|
Vigen-E
|
400 I.U
|
Softgel Capsule.
|
-
|
The ACME Laboratories, Ltd.
|
Bangladesh
|
Initial [OTC]
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14463
|
Cefuroxime (as sodium)
|
Zefriti 750
|
750mg
|
Powder for Injection (IM/IV)
|
-
|
Akriti Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14427
|
Tenofovir Disoproxil Fumarate
|
Hivar
|
300mg
|
Film-Coated Tablet
|
-
|
Simpex Pharma Pvt. Ltd.
|
India
|
Initial (Reapplication)
|
05 September 2023
|
05 September 2028
|
View |
|
DR-XY48868
|
Colecalciferol
|
D-Rize
|
800 IU
|
Softgel Capsule
|
-
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Initial [OTC
|
06 September 2023
|
06 September 2025
|
View |
|
HRP-629
|
Chlorhexidine Gluconate + Ethyl Alcohol
|
None
|
0.5 g/100mL (0.5% w/v) + 70mL/100mL (70% v/v)
|
Solution
|
-
|
Philmed Laboratories, Inc.
|
Philippines
|
Initial [HR]
|
07 September 2023
|
07 September 2028
|
View |
|
DRP-14443
|
Cetirizine Hydrochloride
|
None
|
10 mg
|
Tablet
|
-
|
Wintech Pharmaceuticals Ltd.
|
India
|
Initial [OTC]
|
06 September 2023
|
06 September 2028
|
View |
|
DRP-14401
|
Diltiazem hydrochloride
|
Diltimax
|
60mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14464
|
Cinnarizine
|
Rizine
|
25 mg
|
Film-Coated Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14457
|
Diosmin Hesperidin
|
Hemorfen
|
450 mg/50 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Initial (OTC)
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14484
|
Potassium citrate
|
Kycitrate
|
1.620 g (15 mEq)
|
Extended-Release Tablet
|
-
|
Cooper Pharma Limited
|
India
|
Initial
|
12 September 2023
|
12 September 2028
|
View |
|
DRP-14488
|
Irbesartan + Hydrochlorothiazide
|
Irzid
|
300 mg/25 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
india
|
Initial
|
13 September 2023
|
13 September 2028
|
View |
|
DRP-14487
|
Ascorbic Acid + d-Alpha Tocopherol (Vitamin E) + Zinc
|
Vita-E Plus
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) /22 IU/10 mg (equivalent to 27.45 mg Zinc Sulfate Monohydrate)
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
12 September 2023
|
12 September 2028
|
View |
|
DRP-14486
|
Ascorbic Acid + d-Alpha Tocopherol (Vitamin E) + Zinc
|
Lyra E Plus
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) /22 IU/10 mg (equivalent to 27.45 mg Zinc Sulfate. Monohydrate)
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation
|
Philippines
|
Initial
|
12 September 2023
|
12 September 2028
|
View |
|
DRP-14402
|
Amikacin (as sulfate)
|
Aminica
|
125 mg/mL (250 mg/2 mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Anhui Chengshi Pharmaceutical Co., Ltd.
|
China
|
Initial
|
05 September 2023
|
05 September 2028
|
View |
|
DRP-14467
|
Fosfomycin (as trometamol)
|
Fosfostal
|
3 g per sachet
|
Powder For Oral Solution
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
08 September 2023
|
08 September 2028
|
View |
|
DRP-14495
|
Bortezomib
|
Vortestar 3.5
|
3.5 mg
|
Lyophilized Powder for Injection (IV/SC)
|
-
|
Admac Lifesciences
|
India
|
Initial
|
13 September 2023
|
13 September 2028
|
View |
|
DRP-14442
|
Dabigatran Etexilate (as mesilate)
|
Stabigran 75
|
75 mg
|
Capsule
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
07 September 2023
|
05 September 2028
|
View |
|
DRP-14441
|
Dabigatran Etexilate (as mesilate)
|
Stabigran 110
|
110 mg
|
Capsule
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|
View |
|
DRP-14440
|
Dabigatran Etexilate (as mesilate)
|
Stabigran 150
|
150 mg
|
Capsule
|
-
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
05 September 2023
|
05 September 2028
|