| View |
|
DRP-12442
|
Boric Acid + Borax
|
Borixisaph
|
10 mg/2.5 mg (1%/0.25% v/v)
|
Ophthalmic Solution
|
Lubricant
|
Kilitch Drugs (India)
|
India
|
Initial (OTC)
|
15 August 2022
|
15 August 2027
|
| View |
|
DRHR-2146
|
Zinc Oxide
|
Cetaphil Baby
|
80 mg/g
|
Diaper Cream
|
-
|
Voyant Beauty, Inc.
|
Canada
|
Initial (HR)
|
11 August 2022
|
11 August 2027
|
| View |
|
DRP-12443
|
Mometasone Furoate
|
Mmcort
|
1 mg/g (0.1% w/w)
|
Topical Cream
|
Corticosteroid
|
KLM Laboratories Pvt. Ltd.
|
India
|
Initial (OTC)
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-12438
|
Ascorbic Acid
|
Ascorsaph
|
1000 mg (equivalent to 1124.86 mg Sodium Ascorbate)
|
Capsule
|
Vitamins
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-12439
|
Ascorbic Acid + Zinc
|
Azeesaph
|
1000 mg (equivalent to 1053 mg Sodium Ascorbate)/ 20 mg (equivalent to 55 mg Zinc Sulfate Monohydrate)
|
Film-Coated Tablet
|
Vitamin / Mineral
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial (OTC)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY4821
|
Vitamin B Complex + Inositol + Choline Bitartrate
|
Balanced B-100
|
Formulation: Each tablet contains:
Thiamine Mononitrate (Vitamin B1)-100mg Riboflavin (Vitamin B2)-100mg Niacinamide (Vitamin B3)-100mg Pyridoxine hydrochloride (Vitamin B6)-100 mg Calcium Pantothenate-100 mg
Inositol-100 mg Choline Bitartrate-45mg Folic Acid-400mcg Cyanocobalamin (Vitamin B12)-100mcg Biotin (Vitamin B7)-100mcg
|
Tablet
|
-
|
Nexgen Pharma, Inc.
|
United States of America
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-12214
|
Fluconazole
|
Saphflucaz
|
150 mg
|
Capsule
|
Antifungal
|
Sapphire Lifesciences Pvt. Ltd.
|
India
|
Initial
|
12 August 2022
|
12 August 2027
|
| View |
|
DR-XY 48289
|
Aciclovir + Hydrocortisone
|
None
|
50 mg/10 mg per gram (5%/1% w/w)
|
Topical Cream
|
Antiviral-Corticosteroid Combination
|
Asian Antibiotics, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY 48288
|
Fenofibric Acid
|
None
|
105 mg
|
Softgel Capsule
|
Lipid Modifying Agent
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48287
|
Fenofibric Acid
|
None
|
35 mg
|
Softgel Capsule
|
Lipid Modifying Agent
|
Amherst Laboratories, Inc.
|
Philippines
|
Monitored Release (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48290
|
Montelukast (as sodium) + Levocetirizine hydrochloride
|
Monvex-L
|
10 mg / 5 mg
|
Tablet
|
-
|
West Coast Pharmaceutical Works Ltd.
|
India
|
Initial (Re-application)
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-12465
|
Paclitaxel
|
Taxaica-100
|
6 mg/mL (100 mg/ 16.7 mL)
|
Concentrate Solution for
IV Infusion
|
-
|
Admac Lifesciences
|
india
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-12464
|
Paclitaxel
|
Taxaica-260
|
6 mg/mL (260 mg/43.4 mL)
|
Concentrate Solution for
IV Infusion
|
Antineoplastic agent (Taxane)
|
Admac Lifesciences
|
india
|
Initial
|
15 August 2022
|
15 August 2027
|
| View |
|
DR-XY48277
|
Myox
|
Etoricoxib
|
120 mg
|
Film-Coated Tablet
|
-
|
Cadila Pharmaceuticals Limited
|
India
|
Initial
|
11 August 2022
|
11 August 2027
|
| View |
|
DRP 1858
|
Metoprolol Tartrate
|
Prolol
|
50 mg
|
Tablet
|
-
|
Centurion Laboratories Pvt. Ltd.
|
India
|
Initial (Variation)
|
15 August 2022
|
15 August 2027
|
| View |
|
DRP-9678
|
Ascorbic Acid + Zinc
|
Zryt-XR
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate)/10 mg (equivalent to 43.97 Zinc Sulfate Heptahydrate)
|
Capsule
|
-
|
Scheele Laboratories Phils., Inc.
|
Philippines
|
Initial (OTC][PCPR) [Correction]
|
11 August 2022
|
28 April 2026
|
| View |
DR-XY48283_PI_01.pdf
|
DR-XY48283
|
Dolutegravir (as sodium)
|
None
|
50 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Monitored Release (Reconstruction)
|
24 January 2023
|
15 August 2027
|
| View |
DR-XY48285_PI_01.pdf
|
DR-XY48285
|
Dolutegravir (as sodium) + Emtricitabine + Tenofovir
alafenamide (as fumarate)
|
Kocitaf
|
50 mg/200 mg/25 mg
|
Film-Coated Tablet
|
Direct Acting Antiviral
|
Mylan Laboratories Limited
|
India
|
Monitored Release (Reconstruction)
|
07 March 2023
|
15 August 2027
|
| View |
|
DR-XY48291
|
Atorvastatin (as Calcium) + Fenofibrate
|
Fenostat
|
40 mg/160 mg
|
Film-Coated Tablet
|
-
|
Ajanta Pharma Limited
|
India
|
Monitored Release
|
15 August 2022
|
15 August 2025
|
| View |
DR-XY48276_PI_01.pdf
|
DR-XY48276
|
Fimasartan potassium + Amlodipine (as besilate)
|
Dukarb
|
60 mg/10 mg
|
Film-Coated Tablet
|
-
|
Boryung Pharmaceutical Co., ltd.
|
Korea
|
Monitored Release
|
11 August 2022
|
11 August 2025
|