| View |
DRP-13411_PI_01.pdf
|
DRP-13411
|
Febuxostat
|
Feblorika-40
|
40mg
|
Tablets
|
-
|
Mankind Pharma Limited (Unit II)
|
India
|
Initial
|
16 February 2023
|
16 February 2028
|
| View |
BR-1439_PI_01.pdf
|
BR-1439
|
Amivantamab
|
Rybrevant
|
350 mg/7 mL (50mg/mL)
|
Concentrate For Solution For Infusion (IV)
|
-
|
Cilag AG
|
Switzerland
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48621
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
200 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48623
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48622
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
|
DRP-13397
|
Cholecalciferol (Vitamin D3
|
Vitasaphd3-2000
|
2000 IU
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt.Ltd.
|
India
|
Initial (OTC)
|
22 February 2023
|
22 February 2028
|
| View |
|
DRP-13471
|
Cholecalciferol (Vitamin D3
|
Vitasaphd3-5000
|
5000 IU
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt.Ltd.
|
India
|
Initial (OTC)
|
22 February 2023
|
22 February 2028
|
| View |
|
DRP-13433
|
Ketotifen (As Hydrogen Fumarate)
|
Saphtifen
|
1mg/5mL
|
Syrup
|
-
|
Azine Healthcare Pvt. Ltd.
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|
| View |
|
DRP-13398
|
Diclofenac Diethylamine
|
Fastgenic
|
10mg/g (1% w/w)
|
Topical Gel
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial (OTC)
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13434
|
Ketorolac Trometamol
|
Trometa
|
30 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48628
|
Riboflavin (Vitamin B2)
|
None
|
100mg
|
Capsule
|
-
|
Arizona Nutritional Supplements
|
United States of America
|
Initial (OTC)
|
15 February 2023
|
15 February 2028
|
| View |
DRP-13441_PI_01.pdf
|
DRP-13441
|
Eplerenone
|
Epnone 50
|
50mg
|
Film-Coated Tablet
|
Aldosterone Antagonist
|
MSN Laboratories Private Limited (Formulations
Division)
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|
| View |
DRP-13429_PI_01.pdf
|
DRP-13429
|
Dobutamine (as Hydrochloride)
|
Cardin
|
50 mg/mL (250mg/5mL)
|
Solution for Injection for I.V.
Infusion
|
-
|
Swiss Parenterals Ltd. (Block-B)
|
India
|
Initial
|
16 February 2023
|
16 February 2028
|
| View |
|
DR-XY48625
|
Ascorbic Acid + Zinc (as Bisglycinate)
|
None
|
889 mg (equivalent to 1g Sodium Ascorbate)
|
Effervescent Tablet (Grape Flavor)
|
-
|
Yuesheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
15 February 2023
|
15 February 2028
|
| View |
|
DRHR-2201
|
Menthol + Methyl Salicylate + Camphor
|
Efficascent
|
14 g/10 g/3.5 g per 100 g
|
Ointment
|
-
|
International Pharmaceuticals, Inc.
|
Philippines
|
Initial (HR)
|
21 February 2023
|
21 February 2028
|
| View |
|
DRP-13368
|
Mupirocin
|
Mupinate
|
20 mg/g (2% w/w)
|
Ointment
|
-
|
Curetech Skincare
|
India
|
Initial (OTC)
|
21 February 2023
|
21 February 2028
|
| View |
|
DRP-13367
|
Bromhexine Hydrochloride
|
Sydenhex
|
8 mg/5 mL
|
Syrup (Strawberry Flavor)
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
21 February 2023
|
21 February 2028
|
| View |
|
DRP-13366
|
Bromhexine Hydrochloride
|
Sybromex
|
4 mg/5 mL
|
Syrup (Strawberry Flavor)
|
-
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
21 February 2023
|
21 February 2028
|
| View |
|
DRHR-2207
|
Isopropyl Alcohol
|
Huntergreen
|
70% (v/v)
|
Solution
|
-
|
Kohl Industries Corporation.
|
Philippines
|
Initial (HR)
|
15 February 2023
|
15 February 2028
|
| View |
|
DRP-13412
|
Spironolactone
|
Urinasaph-S
|
100 mg
|
Film-Coated Tablet
|
-
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
17 February 2023
|
17 February 2028
|