| View |
|
DR-XY48408
|
Indacaterol (as acetate) + Glycopyrronium (as bromide)
+ Mometasone Furoate
|
None
|
150 mcg/ 50 mcg/ 80 mcg
|
Powder for Inhalation in Hard Capsule
|
Selective Beta-2 adrenoreceptor Agonist/
Anticholinergic/ Corticosteroid
|
Novartis Pharma Stein AG
|
Switzerland
|
Monitored Release
|
07 October 2022
|
07 October 2025
|
| View |
|
DR-XY48409
|
Pralsetinib
|
Gavreto
|
100 mg
|
Capsule
|
Antineoplastic Agent
|
Catalent CTS, LLC.
|
United States of America
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
DR-XY48410_PI_01.pdf
|
DR-XY48410
|
Trifluridine + Tipiracil (as Hydrochloride)
|
Lonsurf
|
20 mg/8.19 mg
|
Film-Coated Tablet
|
Antineoplastic Agents
|
Taiho Pharmaceutical Co., Ltd. (Kitajima Plant)
|
Japan
|
Monitored Release (Reconstruction)
|
19 October 2023
|
07 October 2027
|
| View |
DR-XY48411_PI_01.pdf
|
DR-XY48411
|
Trifluridine + Tipiracil (as Hydrochloride)
|
Lonsurf
|
15 mg/6.14 mg
|
Film-Coated Tablet
|
-
|
Taiho Pharmaceutical Co., Ltd. (Kitajima Plant)
|
Japan
|
Monitored Release (Reconstruction)
|
19 October 2023
|
07 October 2027
|
| View |
|
DR-XY48412
|
Ropivacaine Hydrochloride
|
Rocaine
|
10 mg/mL (100 mg/10 mL)
|
Solution for Injection (I.V.)
|
-
|
Biomendi, S.A.
|
Spain
|
DR-XY48412
|
06 March 2023
|
07 October 2027
|
| View |
DR-XY48413_PI_01.pdf
|
DR-XY48413
|
Trifarotene
|
Aklief
|
50 mcg/g
|
Cream
|
Anti-Acne
|
Laboratories Galderma
|
France
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
DR-XY48414_PI_01.pdf
|
DR-XY48414
|
Sodium Chloride
|
Axaline 3.0%
|
30mg/mL (3% w/v)
|
Solution for Intravenous Infusion
|
Hypertonic Solution
|
Axa Parenterals Limited
|
India
|
Monitored Release
|
07 October 2022
|
07 October 2027
|
| View |
|
DR-XY48415
|
Sterile Water for Injection
|
None
|
10 mL
|
Sterile Water for Injectio
|
Parenteral Diluent
|
CSPC Ouyi Pharmaceutical Co. Ltd.
|
China
|
Initial
|
12 October 2022
|
12 October 2027
|
| View |
|
DR-XY48416
|
Vitamin B-Complex
|
None
|
Formulation:
Each capsule contains:
Thiamine Hydrochloride (Vitamin B)..........50 mg Riboflavin (Vitamin B2)...........................50 mg Niacinamide (Vitamin B1).....................50 mg Pantothenic Acid (Vitamin Bs)..................50 mg Pyridoxine Hydrochloride (Vitamin B.).......50 mg Para-aminobenzoic acid (PABA)...............50 mg
Folic Acid (Vitamin B,)................1 mg Biotin (Vitamin B7).............................60 mcg Cyanocobalamin (Vitamin B12)............50 mcg Choline Bitartrate............. 50 mg Inositol............... 50 mg
|
Capsule
|
Vitamins
|
Factors Group of Nutritional Companies Inc.
|
Canada
|
Initial (Re-Application)
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48417
|
Calcium Carbonate + Colecalciferol (Vitamin D3)
|
None
|
500 mg/ 200 IU
|
Film-Coated Tablet
|
-
|
Factors Group of Nutritional Companies Inc
|
Canada
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48418_PI_01.pdf
|
DR-XY48418
|
Vericiguat
|
Verquvo
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48419_PI_01.pdf
|
DR-XY48419
|
Vericiguat
|
Verquvo
|
5 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
DR-XY48420_PI_01.pdf
|
DR-XY48420
|
Vericiguat
|
Verquvo
|
10 mg
|
Film-Coated Tablet
|
-
|
Bayer AG
|
|
Monitored Release
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48421
|
Ascorbic Acid + dl-Alpha Tocopheryl Acetate
(Vitamin E)
|
MyBeaute
|
500 mg / 12 mg per Capsule
|
Capsule
|
Vitamins
|
Compact Pharmaceuticals, Corp.
|
Philippines
|
Initial (OTC)
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48422
|
Ticagrelor
|
Cleverge
|
90 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Platelet Aggregation Inhibitor excl. heparin)
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
13 October 2022
|
13 October 2027
|
| View |
|
DR-XY48423
|
Thiamine Hydrochloride (Vitamin B1) +
Pyridoxine Hydrochloride (Vitamin B6) +
Cyanocobalamin (Vitamin B12)
|
Faranerv-B
|
100 mg/100 mg/1 mg per 3 mL
|
Solution for Injection (IM/IV)
|
Vitamins
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
25 October 2022
|
25 October 2027
|
| View |
|
DR-XY48424
|
Pregabalin
|
Pregeb 50
|
50 mg
|
Capsule
|
Antiepileptic
|
Torrent Pharmaceuticals Ltd.
|
India
|
Initial
|
18 October 2022
|
18 October 2027
|
| View |
|
DR-XY48425
|
Febuxostat
|
Vexbos 80
|
80 mg
|
Film-Coated Tablet
|
Antigout preparation
|
ACME Formulation Pvt. Ltd.
|
India
|
Initial
|
26 October 2022
|
26 October 2027
|
| View |
|
DR-XY48426
|
Doxycycline (as hyclate)
|
Dynadoxy
|
100mg
|
Capsule
|
Antibacterial (Tetracycline)
|
Swiss Pharmaceutical Co., Ltd. (Xinshi Plant)
|
Taiwan
|
Initial (Re-appplication)
|
03 November 2022
|
03 November 2027
|
| View |
|
DR-XY48427
|
Cefuroxime (as sodium)
|
Eoroxime-750
|
750 mg
|
Powder for Injection (IM/IV)
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
16 November 2022
|
16 November 2027
|