| View |
|
DRP-12536
|
Clonidine Hydrochloride
|
Control
|
150 mcg
|
Tablet
|
Antihypertensive (Centrally Acting Antiadrenergic
Agent)
|
Globela Pharma Private Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12559
|
Ascorbic Acid + Zinc + Vitamin D3 + Vitamin E
|
Dayzinc Fortified
|
500 mg (equivalent to 562.4 mg Sodium Ascorbate)/ 10 mg Capsule (equivalent to 27.5 mg Zinc Sulphate Monohydrate)/1000 IU/ 15 mg
|
Capsule
|
Vitamins :
|
Novagen Pharmaceutical Co., Inc.
|
Philippines
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DR-XY48316
|
Fosfomycin (as trometamol)
|
Fosmol
|
3 g
|
Granules For Oral Solution
|
Antibacterial
|
Labiana Pharmaceuticals, S.1. U
|
Spain
|
Initial (Re-Application)
|
26 August 2022
|
26 August 2027
|
| View |
|
DRP-12549
|
Sitagliptin (As Phosphate)
|
Diawell
|
50mg
|
Film-Coated Tablet
|
-
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DRP-12548
|
Sitagliptin (As Phosphate)
|
Diawell
|
100mg
|
Film-Coated Tablet
|
Dipeptidyl peptidase 4 (DPP-4) inhibitor
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DR-XY48328
|
Sunitinib (as maleate)
|
Nibsutib
|
12.5 mg
|
Capsule
|
Antineoplastic Agent (Protein Kinase Inhibitor)
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
Initial
|
31 August 2022
|
31 August 2027
|
| View |
|
DR-XY48335
|
Clobazam
|
Yogazam
|
10 mg
|
Tablet
|
Anxiolytic (Benzodiazepine derivative)
|
Micro Labs Limited
|
India
|
Monitored Release (Re-application)
|
02 September 2022
|
02 September 2027
|
| View |
|
DR-XY48336
|
Clobazam
|
Yogazam
|
20 mg
|
Tablet
|
-
|
Micro Labs Limited
|
India
|
Monitored Release (Re-application)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12535
|
Metronidazole
|
Metrosaph
|
5 mg/mL (500 mg/100 mL)
|
Solution for Injection
(IV Infusion)
|
Antibacterial/Antiprotozoal (Nitroimidazole
Derivative)
|
Jedux Parenteral Private Limited
|
India
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12566
|
Sodium Alginate + Sodium Bicarbonate + Calcium Carbonate
|
Gascovid
|
50mg/26.7mg/16mg per mL
|
Suspension (Peppermint Flavor)
|
Antacid
|
Hovid Berhad
|
Malaysia
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12558
|
Diosmin + Hesperidin
|
None
|
450 mg/50 mg
|
Film-Coated Tablet
|
Vasoprotective
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
HRP-540
|
Calamine + Zinc Oxide
|
None
|
50 mg160 mg per gram (5%/16% w/w)
|
Topical Cream
|
-
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12563
|
Ascorbic Acid + Zinc
|
Myrevit-C Plus
|
500 mg (equivalent to 562.43mg Sodium Ascorbate)/10 mg (equivalent to 27.45 mg Zinc
Sulfate Monohydrate)
|
Film Coated Tablet
|
Vitamin/Mineral
|
New Myrex Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12565
|
Ascorbic Acid + Zinc
|
Unbranded
|
500 mg (equivalent to 568.18mg Sodium Ascorbate)/10 mg (equivalent to 27.5mg Zinc Sulfate Monohydrate)
|
Film-Coated Tablet
|
VItamin/Mineral
|
Novagen Healthcare Pvt. Ltd.
|
India
|
Renewal
|
01 March 2024
|
02 September 2029
|
| View |
|
DRP-12534
|
Metronidazole
|
Metrovee
|
5 mg/mL (500 mg/100 mL)
|
Solution for Injection
(IV Infusion)
|
Antibacterial/Antiprotozoal (Nitroimidazole
Derivative)
|
Hebei Tiancheng Pharmaceutical Co., Ltd.
|
China
|
Initial
|
30 August 2022
|
30 August 2027
|
| View |
|
DRP-12567
|
Ketoconazole
|
Derkazole
|
20 mg/g (2% w/w)
|
Cream
|
Antifungal
|
Lincoln Pharmaceuticals Ltd.
|
india
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12556
|
Diosmin + Hesperidin
|
VenoSolv
|
450 mg/50 mg
|
Film-Coated Tablet
|
Vasoprotective
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12557
|
Multivitamins
|
Saphtivit
|
REMARKS: Formulation Each 5 mL contains: Retinol Palmitate (Vitamin A)-4000 IU Cholecalciferol (Vitamin D3)-400 IU dl-a-Tocopheryl Acetate (Vitamin E)-2 IU Ascorbic Acid (Vitamin C)-75 mg Niacin (Vitamin B3)-10 mg Thiamine Hydrochloride (Vitamin B1)-5mg Riboflavin-5-Sodium Phosphate (Vitamin B2)-2 mg Pyridoxine Hydrochloride (Vitamin B6)- 2 mg Cyanocobalamin (Vitamin B12)-1 mcg
|
Syrup
|
Vitamin
|
Enicar Pharmaceutical Pvt. Ltd
|
India
|
Initial (OTC)
|
02 September 2022
|
02 September 2027
|
| View |
|
DRP-12496
|
Vancomycin (as hydrochloride)
|
Vancolife
|
1 g
|
Lyophilized Powder for Injection for I.V. Infusion
|
-
|
BCWorld Pharm. Co., Ltd.
|
Korea
|
Initial (Re-application)
|
26 August 2022
|
26 August 2027
|
| View |
|
DR-XY48325
|
Naratriptan (as hydrochloride)
|
Nargraine
|
2.5 mg
|
Film-Coated Tablet
|
Antimigraine (Selective serotonin (5-HT1] Receptor Agonists
|
Chanelle Medical
|
Ireland
|
Monitored Release
|
31 August 2022
|
31 August 2027
|