| View |
|
DRP-13684
|
Clindamycin (as hydrochloride)
|
Clindasaph
|
150 mg
|
Capsule
|
Antibacterial (Lincosamide)
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (Correction)
|
29 May 2024
|
28 March 2028
|
| View |
|
DRP-13704
|
Betahistine hydrochloride
|
Histakon
|
16 mg
|
Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
|
Initial
|
29 March 2023
|
29 March 2028
|
| View |
|
DRP-13667
|
Azithromycin (as dihydrate)
|
Zithrox
|
500 mg
|
Lyophilized Powder For IV Injection
|
-
|
Hainan Brilliant Pharmaceutical Co., Ltd.
|
|
Initial
|
27 March 2023
|
27 March 2028
|
| View |
|
DRP-13632
|
Timolol (As Maleate)
|
Timosaph
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution (Eye Drops)
|
-
|
Health Biotech Ltd.
|
|
Initial
|
21 March 2023
|
21 March 2028
|
| View |
|
DRP-13651
|
Epirubicin hydrochloride
|
Epirubisaph-100
|
100 mg
|
Lyophilized Powder for IV Infusion
|
-
|
Bruck Pharma Private Limited
|
|
Initial
|
23 March 2023
|
23 March 2028
|
| View |
|
DR-XY48661
|
Cloxacillin (as sodium)
|
Cloxispa-250
|
250 mg/5 mL
|
Powder for Oral Solution
|
-
|
Sparsh Bio-tech Pvt., Ltd.
|
|
Initial
|
22 March 2023
|
22 March 2028
|
| View |
|
DRP-13695
|
Ceftriaxone (as sodium)
|
Ceftribax
|
1 g
|
Powder for Injection (I.M./I.V.).
|
-
|
Reyoung Pharmaceutical Co. Ltd.
|
|
Initial
|
29 March 2023
|
29 March 2028
|
| View |
|
DRP-13679
|
Tadalafil
|
Robust-T
|
20 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DRP-13680
|
Tadalafil
|
None
|
20 mg
|
Film-Coated Tablet
|
-
|
Phil. United Pharma Corporation.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DRP-13626
|
Betamethasone (as dipropionate)
|
None
|
500 mcg per gram (0.5% w/w)
|
Cream
|
-
|
Agio Pharmaceuticals Ltd.
|
|
Initial
|
21 March 2023
|
21 March 2028
|
| View |
DRP-13647_PI_01.pdf
|
DRP-13647
|
Pregabalin
|
Rebalin 75
|
75 mg
|
Capsule
|
Antiepileptic
|
Sunglow Lifescience Private Limited
|
India
|
Initial (Reconstruction)
|
10 September 2024
|
22 March 2028
|
| View |
|
DRP-13645
|
Sitagliptin (as phosphate)
|
Sitfar
|
50 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
|
Initial
|
22 March 2023
|
22 March 2028
|
| View |
|
DRP-13646
|
Sitagliptin (as phosphate)
|
Sitfar
|
100 mg
|
Film-Coated Tablet
|
-
|
Magbro Healthcare Pvt. Ltd.
|
|
Initial
|
22 March 2023
|
22 March 2028
|
| View |
|
DRP-13701
|
Amikacin (as sulfate)
|
Ambikacin-500
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(I.M./I.V.)
|
-
|
Cooper Pharma Limited
|
|
Initial
|
29 March 2023
|
29 March 2028
|
| View |
|
DR-XY48651
|
Candesartan cilexetil
|
Hyperest
|
16 mg
|
Tablet
|
-
|
Laboratorios Liconsa, S.A.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DR-XY 48652
|
Candesartan cilexetil
|
Hyperest
|
8 mg
|
Tablet
|
-
|
Laboratorios Liconsa, S.A.
|
|
Initial
|
24 March 2023
|
24 March 2028
|
| View |
|
DRHR-2227
|
Menthol
|
FlanaxCool
|
40 mg/g (4% w/w)
|
Topical Gel
|
Counterirritant
|
PT. Taisho Pharmaceutical Indonesia TBK.
|
Indonesia
|
Initial
|
29 March 2023
|
29 March 2028
|
| View |
|
DRHR-2228
|
Methyl Salicylate + Menthol + Eugenol
|
FlanaxHot
|
102 mg/ 54.35 mg/ 13.65 mg per gram
|
Topical Cream
|
-
|
PT. Taisho Pharmaceutical Indonesia TBK.
|
Indonesia
|
Initial
|
29 March 2023
|
29 March 2028
|
| View |
|
DRP-13627
|
Co-Amoxiclav
|
Cowamox
|
1.2 g
|
Powder for IV Injection
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
|
Initial
|
23 March 2023
|
23 March 2028
|
| View |
|
DR-XY48663
|
Moxifloxacin (as hydrochloride)
|
Pol-Moxi
|
400 mg/ 250 mL
|
Solution for I.V. Infusion
|
-
|
Polifarma Ilac San Ve. Tic. A.S.
|
|
Initial
|
22 March 2023
|
22 March 2028
|