| View |
|
DRP-14863
|
Sevelamer Carbonate
|
Selvenorm
|
800 mg
|
Film-Coated Tablet
|
Phosphate Binder
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DRP-14864
|
Sevelamer Carbonate
|
Bersevel
|
800 mg
|
Film-Coated Tablet
|
Phosphate Binder
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
25 January 2024
|
25 January 2029
|
| View |
|
DR-XY48995
|
Aluminum hydroxide + Magnesium hydroxide +
Simethicone
|
Contylan Advance
|
225 mg/200 mg/30 mg
|
Tablet
|
Antacid/Antiflatulent
|
Lejal Laboratories, Inc.
|
Philippines
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP 14370
|
Clobetasol Propionate
|
Easekin
|
25 mg/g (0.05%w/w)
|
Cream
|
Topical Corticosteroid
|
Synmedic Laboratories
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
|
DRP-14872
|
Bilastine
|
Bilwin 20
|
20 mg
|
Tablet
|
Antihistamine
|
Stallion Laboratories Pvt. Ltd.
|
India
|
Initial
|
26 January 2024
|
26 January 2029
|
| View |
|
DRP-14888
|
Metformin hydrochloride
|
Xomet
|
500mg
|
Film-Coated Tablet
|
Blood Glucose-Lowering Drug (Biguanide)
|
Fredun Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DR-XY48994
|
Moxifloxacin (as hydrochloride)
|
None
|
400mg
|
Film-Coated Tablet
|
Antibacterial (Fluoroquinolone)
|
Lupin Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14866
|
Sevoflurane
|
Sevollen
|
100% v/v
|
Volatile Liquid for Inhalation.
|
General Anesthetic
|
Enicar Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
29 January 2024
|
29 January 2029
|
| View |
|
DRP-14880
|
Ofloxacin
|
Ofloxasaph-INF
|
3 mg/mL (0.3% w/v)
|
Ophthalmic Solution (Eye Drops)
|
Antibacterial (Fluoroquinolone)
|
Kilitch Drugs (India) Ltd.
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14879
|
Rosuvastatin (as calcium)
|
Glenraz 5
|
5 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14878
|
Rosuvastatin (as calcium)
|
Glenraz 10
|
10 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14877
|
Rosuvastatin (as calcium)
|
Glenraz 40
|
40 mg
|
Film-Coated Tablet
|
Lipid Modifying Agent (HMG CoA Reductase Inhibitor)
|
Glenmark Pharmaceuticals Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14881
|
Escitalopram (as oxalate)
|
Nexito 10
|
10 mg
|
Film-Coated Tablet
|
Antiepileptic
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14882
|
Escitalopram (as oxalate)
|
Nexito 20
|
20 mg
|
Film-Coated Tablet
|
Antidepressant [Selective
Inhibitor (SSRI)]
|
Sun Pharmaceutical Industries Limited
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14884
|
Oxymetazoline hydrochloride.
|
Nasathix
|
250 mcg/mL (0.025% w/v)
|
Nasal Spray
|
Nasal Decongestant
|
Biodeal Pharmaceuticals Pvt. Ltd.
|
India
|
Initial
|
31 January 2024
|
31 January 2026
|
| View |
|
DRP-14883
|
Multivitamins + Minerals.
|
Eurominvit
|
Each Film-Coated Tablet contains:
Ascorbic Acid (Vitamin C) 50 mg
Thiamine Mononitrate (Vitamin B1) 2.5 mg
Riboflavin (Vitamin B2) 2.5 mg
Retinol Acetate (Vitamin A) 5,000 IU
(equivalent to Retinol 1.5 mg)
Cholecalciferol (Vitamin D1) 400 IU
d-alpha tocopherol Acetate 10 IU
Pyridoxine Hydrochloride (Vitamin B6) 500 mcg
Cyanocobalamin (Vitamin B12) 2 mcg
Calcium 35mg
Nicotinamide 20 mg
Iron 10 mg
Magnesium 6 mg
Calcium Pantothenate 5 mg
Potassium 5 mg
Manganese 1 mg
|
Film Coated Tablet
|
Vitamins/Minerals
|
Azarias Pharmaceutical Laboratories Inc.
|
Philippines
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14875
|
Levocetirizine Hydrochloride
|
Iztaid
|
2.5mg/5mL
|
Syrup
|
Antihistamine (Piperazine Derivative)
|
Azarias Pharmaceutical Laboratories Inc.,
|
Philippines
|
Initial
|
30 January 2024
|
30 January 2029
|
| View |
|
DRP-14876
|
Levocetirizine Hydrochloride
|
Iztaid
|
5mg
|
Film-Coated Tablet
|
Antihistamine (Piperazine Derivative)
|
Azarias Pharmaceutical Laboratories Inc
|
Philippines
|
Initial
|
30 January 2024
|
30 January 2029
|
| View |
|
DRP-14889
|
Moxifloxacin (as hydrochloride)
|
Optiwell
|
5 mg/mL (0.5% w/v)
|
Ophthalmic Solution
|
Anti-infective (Fluoroquinolone)
|
Indoco Remedies Limited Plant II
|
India
|
Initial
|
31 January 2024
|
31 January 2029
|
| View |
|
DRP-14890
|
Acetylcysteine
|
Synucil
|
200 mg
|
Granules for Oral Solution
|
Mucolytic
|
Sydenham Laboratories, Inc.
|
Philippines
|
Initial
|
01 February 2024
|
01 February 2029
|