| View |
|
DRP-14842
|
Linagliptin + Metformin Hydrochloride
|
Myglip Plus 2.5/1000
|
2.5 mg/1 g
|
Film-Coated Tablet
|
-
|
Alidac Healthcare (Myanmar) Ltd.
|
Myanmar
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DR-XY48983
|
Retinol Palmitate (Vitamin A) + Ascorbic (Vitamin C) + dl-a-Tocopheryl acetate (Vitamin E) + Pyridoxine (Vitamin B6) + Zinc
|
Vitamace
|
3000 IU/500 mg/100 IU/1.95 mg (equivalent to 2.37 mg Pyridoxine hydrochloride)/25 mg (equivalent to 31.12 mg of Zinc Oxide)
|
Softgel Capsule
|
-
|
Phil Inter Pharma Co. Ltd.
|
Vietnam
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14846
|
Rosuvastatin (as calcium)
|
Rosuu
|
5mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited.
|
India
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14845
|
Rosuvastatin (as calcium)
|
Rosuu
|
10mg
|
Film Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited.
|
India
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14844
|
Rosuvastatin (as calcium)
|
Rosuu
|
20mg
|
Film-Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited.
|
India
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DR-XY48981
|
Pemetrexed (as disodium)
|
Cartrexed
|
500 mg
|
Lyophilized Powder for Injection.
(IV Infusion)
|
-
|
Shanghai Chemo Wanbang Biopharma Co. Ltd.
|
China
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14849
|
Vancomycin hydrochloride
|
Nycovan
|
1 g
|
Powder for Injection (IV Infusion)
|
-
|
Swiss Parenterals Limited
|
India
|
Initial
|
23 January 2024
|
23 January 2026
|
| View |
|
DRP-14847
|
Simethicone
|
Gastrosaph
|
40mg
|
Chewable Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
23 January 2024
|
23 January 2029
|
| View |
|
DRP-14852
|
Metronidazole
|
Acumet
|
5 mg/mL [500 mg/100 mL (0.5% w/v)]
|
Solution for
Intravenous Infusion.
|
-
|
Aculife Healthcare Private Limited
|
India
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
DRP-14851
|
Omeprazole (as sodium)
|
Zolemed
|
40mg
|
Powder for Injection (IV.)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14850
|
Omeprazole (as sodium)
|
Zolemed-WFI
|
40mg
|
Powder for Injection (I.V.
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
BRP-134
|
Trastuzumab
|
Trastumed
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
BRP-132
|
Trastuzumab
|
Herthix
|
150 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DR-XY48984
|
Remdesivir
|
Desrem
|
100 mg
|
Lyophilized Powder for Solution for I.V. Infusion
|
-
|
Gland Pharma Limited
|
India
|
Monitored Release
|
24 January 2024
|
24 January 2029
|
| View |
|
BRP-133
|
Trastuzumab
|
Herthix
|
440 mg
|
Lyophilized Powder for Solution for Infusion (IV)
|
-
|
Reliance Life Sciences Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14859
|
Cefixime (as trihydrate)
|
Cefitome
|
400 mg
|
Film-Coated Tablet
|
-
|
Indchemie Health Specialities Private Limited
|
India
|
Initial
|
24 January 2024
|
24 January 2029
|
| View |
|
DR-XY48990
|
Hydroquinone + Tretinoin
|
None
|
30mg/300mcg per gram
|
Topical Cream
|
-
|
Altum International Cosmeceutical Manufacturing
|
Philippines
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|
| View |
|
DR-XY48989
|
Hydroquinone + Tretinoin
|
None
|
27 mg/100 mcg per mL
|
Topical Solution
|
-
|
Altum International Cosmeceutical Manufacturing
|
Philippines
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14867
|
Ibuprofen
|
Ibuwell
|
400 mg
|
Tablet
|
-
|
S Kant Healthcare Ltd.
|
India
|
Initial |OTC]
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14870
|
Ketoconazole
|
Ketofred
|
20mg/g (2% w/w)
|
Topical Cream
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial [OTC]
|
25 January 2024
|
25 January 2029
|