| View |
|
DRP-14031
|
Telmisartan + Amlodipine (As Besilate)
|
Amcardis
|
80mg/5mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14035
|
Telmisartan + Amlodipine (As Besilate)
|
Telmirx Plus
|
40mg/5mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14034
|
Telmisartan + Amlodipine (As Besilate)
|
Telmirx Plus
|
80mg/5mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14036
|
Telmisartan + Amlodipine (As Besilate)
|
Telmirx Plus
|
40mg/10mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14037
|
Telmisartan + Amlodipine (As Besilate)
|
Telmirx Plus
|
80mg/10mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14032
|
Telmisartan + Amlodipine (As Besilate)
|
Amcardis
|
40mg/10mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited.
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14030
|
Telmisartan + Amlodipine (As Besilate)
|
Amcardis
|
40mg/5mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
|
DRP-14033
|
Telmisartan + Amlodipine (As Besilate)
|
Amcardis
|
80mg/10mg
|
Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
07 June 2023
|
07 June 2028
|
| View |
DRP-14002_PI_01.pdf
|
DRP-14002
|
Ifosfamide
|
Fosfalex
|
1 g
|
Lyophilized Powder for Concentrate for Solution for
IV Infusion
|
-
|
Laboratorio Kemex S.A.
|
Argentina
|
Initial
|
26 September 2023
|
06 June 2028
|
| View |
|
DRP-14041
|
Oxymetazoline Hydrochloride
|
None
|
500 mcg/mL (0.05% w/v)
|
Nasal Spray
|
-
|
Biodeal Pharmaceuticals Pvt., Ltd.
|
India
|
Initial [OTC]
|
08 June 2023
|
08 June 2026
|
| View |
|
DRP-14040
|
Oxymetazoline Hydrochloride
|
None
|
250 mcg/mL (0.025% w/v)
|
Nasal Spray
|
-
|
Biodeal Pharmaceuticals Pvt., Ltd.
|
India
|
Initial [OTC]
|
08 June 2023
|
08 June 2026
|
| View |
|
DRP-14055
|
Dutasteride
|
Dutawell
|
500 mcg
|
Softgel Capsule
|
-
|
Humanwell Puracap Pharmaceuticals (Wuhan) Co. Ltd.
|
China
|
Initial
|
08 June 2023
|
08 June 2028
|
| View |
|
DRP-14064
|
Rivaroxaban
|
Roxavid
|
15mg
|
Film-Coated Tablet
|
-
|
Inventia Healthcare Limited
|
India
|
Initial
|
09 June 2023
|
09 June 2028
|
| View |
|
DRP-14012
|
Atorvastatin (As Calcium)
|
Lestor
|
80mg
|
Film-Coated Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-Application)
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14013
|
Atorvastatin (As Calcium)
|
Lestor
|
40mg
|
Film-Coated Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-Application)
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14014
|
Atorvastatin (As Calcium)
|
Lestor
|
20mg
|
Film-Coated Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-Application)
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14015
|
Atorvastatin (As Calcium)
|
Lestor
|
10mg
|
Film-Coated Tablet
|
-
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-Application)
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-14038
|
Apixaban
|
Pixab
|
2.5 mg
|
Film-Coated Tablet
|
Antithrombotic agent (Direct factor Xa inhibitor)
|
Intas Pharmaceuticals Limited
|
India
|
Initial (Reconstruction)
|
14 May 2024
|
07 June 2028
|
| View |
|
DRP-13848
|
Glimepiride
|
Glymax
|
2mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|
| View |
|
DRP-13847
|
Glimepiride
|
Glymax
|
3mg
|
Tablet
|
-
|
Globela Pharma Private Limited
|
India
|
Initial
|
06 June 2023
|
06 June 2028
|