| View |
|
DR-XY47848
|
Darifenacin (as Hydrobromide)
|
Daritor-15
|
15 mg
|
Extended-Release Tablet
|
Urological
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DR-XY47847
|
Darifenacin (As Hydrobromide)
|
Daritor-7.5
|
7.5 mg
|
Extended-Release Tablet
|
Urological
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-11555
|
Fenofibrate
|
None
|
200 mg
|
Capsule
|
-
|
Athena Drug Delivery Solutions Pvt. Ltd.
|
India
|
-
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-11476
|
Ketoconazole
|
Kzole
|
20mg/g (2% w/w)
|
Topical Cream
|
Antifungal
|
S. Kant Healthcare Limited
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47849
|
Ascorbic Acid + Bioflavonoids
|
Neutrabliss
|
1 g/50 mg
|
Tablet
|
Vitamins
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-11554
|
Dabigatran etexilate (as mesylate)
|
Gribero
|
150 mg
|
Capsule
|
Antithrombotic Agent (Direct Thrombin Inhibitor)
|
MSN Laboratories Private Limited Formulations
Division
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-5403-16
|
Azithromycin (as dihydrate)
|
Azivid-500
|
500 mg
|
Film-coated Tablet
|
Antibacterial (Macrolide)
|
Magbro Healthcare Pvt. Ltd.
|
India
|
Renewal
|
07 July 2024
|
23 July 2029
|
| View |
|
DRP-10199-04
|
Trimetazidine hydrochloride
|
Trimetreve
|
35 mg
|
Modified-Release Tablet
|
Anti-angina
|
Zim Laboratories Limited
|
India
|
CLIDP
|
28 March 2022
|
04 August 2026
|
| View |
|
DR-XY 42062
|
Tolvaptan
|
Samsca
|
15mg
|
Tablet
|
-
|
Korea Otsuka Pharmaceutical Co., Ltd.
|
Korea
|
-
|
30 March 2022
|
23 April 2026
|
| View |
|
DRP-11551
|
Paclitaxel
|
Aplitax
|
6 mg/mL (30 mg/5 mL and 150 mg/25 mL)
|
Concentrate Solution for Injection (IV Infusion)
|
Antineoplastic Agent
|
Sobhan Oncology Co.
|
Iran
|
Initial (Correction)
|
27 June 2022
|
29 March 2027
|
| View |
|
DRP-11588
|
Ofloxacin
|
Oplase
|
3mg/mL (0.3% w/v)
|
Ophthalmic Solution
|
Antibacterial (Fluroquinolone)
|
Skymap Healthcare Pvt. Ltd.
|
India
|
Initial (Correction)
|
15 September 2022
|
30 March 2027
|
| View |
|
DRP-11549
|
Ondansetron (As Hydrochloride)
|
Ondansaph-8
|
2mg/mL(8mg/4mL)
|
Solution for Injection (IM/IV)
|
Antiemetic/Antinauseant (serotonin (HT3) Antagonist)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DR-XY47703
|
Ibuprofen + Phenylpropanolamine Hydrochloride +
Chlorphenamine Maleate
|
Bioflu® Pro
|
200mg / 25 mg / 2mg
|
Capsule
|
Non-Steroidal Anti-inflammatory Drug (Propionic Acid
Derivative) / Nasal Decongestant / Antihistamine
|
PT. Medifarma Laboratories
|
Indonesia
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11546
|
Paracetamol
|
Fastamol
|
1 g/100 mL (10 mg/mL)
|
Solution for Injection (IV Infusion)
|
Analgesic / Antipyretic (Anilide)
|
Eurolife Healthcare Pvt. Ltd.
|
India
|
Initial
|
30 March 2022
|
30 March 2027
|
| View |
|
DRP-11558
|
Multivitamins + Iron
|
Rondvit
|
Formulation: Each 5mL contains:
Niacin (Vitamin B3)............. 10 mg Thiamine Hydrochloride (Vitamin B1).............5 mg Pyridoxine Hydrochloride (Vitamin B6)............5 mg Riboflavin-5' Sodium Phosphate (vitamin B2) ................2 mg Cyanocobalamin (Vitamin B12)..................... 1.8 mcg
Retinol Palmitate ( Vitamin A)................. .2500 IU Cholecalciferol (Vitamin D:)........................ 400 IU d1-alpha Tocopheryl Acetate (Vitamin E)......... 2 IU Iron, (equivalent to 75 mg Ferrous Sulfate)......... 15 mg
|
Syrup (Orange Flavor)
|
Vitamin/Mineral
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial (OTC) (Correction)
|
18 January 2023
|
30 March 2027
|
| View |
|
DR-XY47841
|
Oxytocin
|
Oxyt 10
|
10 IU/mL
|
Solution for Injection (IM/IV)
|
Posterior Pituitary Hormones
|
Steril-Gene Life Sciences (P) Ltd.
|
India
|
Renewal
|
28 April 2024
|
30 March 2029
|
| View |
|
DRP-11557
|
Dextromethorphan Hydrobromide +
Phenylpropanolamine Hydrochloride + Chlorpheniramine
Maleate + Sodium Citrate
|
Saphendex
|
15 mg/10 mg/2 mg/200 mg per 5 mL
|
Syrup (Cherry Flavor)
|
Antitussive/Nasal Decongestant/Antihistamine/Urinary Alkalizer
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
29 March 2022
|
29 March 2027
|
| View |
|
DR-XY47836
|
Ivermectin
|
None
|
5mg/ g (0.5% w/w)
|
Lotion
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
29 March 2022
|
29 March 2027
|
| View |
|
DR-XY47835
|
Ivermectin
|
None
|
5mg/ g (0.5% w/w)
|
Lotion
|
-
|
Amherst Laboratories, Inc.
|
Philippines
|
-
|
29 March 2022
|
29 March 2027
|
| View |
|
DRP-11584
|
Everolimus
|
Everbliss 5
|
5mg
|
Tablet
|
-
|
BDR Pharmaceuticals International Pvt. Ltd. (Oncology Unit)
|
India
|
-
|
30 March 2022
|
30 March 2027
|