| View |
|
DR-XY48629
|
Vinorelbine (as tartrate)
|
Vinotel
|
10 mg/mL
|
Solution For I.V. Infusion
|
-
|
Fresenius Kabi Oncology Limited.
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DR-XY48630
|
Multivitamins + Minerals + Chlorella pyrenoidosa +
Panax ginseng L. (Korean Ginseng) Root + Lecithin +
Rutin + Taurine
|
Restor-F
|
Each softgel capsule contains: Retinyl Palmitate (Vitamin A)-2700 IU Cholecalciferol (Vitamin D3)-200 IU Ascorbic Acid (Vitamin C)-60 mg Niacinamide (Vitamin B3)-30 mg dl-Alpha Tocopheryl Acetate (Vitamin E)-10 mg Pyridoxine (Vitamin B6)-3 mg Thiamine (Vitamin B1)-1.8 mg Riboflavin (Vitamin B2)-1.8 mg Folic Acid (Vitamin B9)-250 mcg Cyanocobalamin (Vitamin B12) -3mcg
Calcium (Equivalent to 50mg Calcium Carbonate)-20 mg Iron (Equivalent to 30.77mg Ferrous Fumarate)-10 mg Zinc (Equivalent to 27.45mg Zinc Sulfate Monohydrate) -10 mg
Chlorella pyrenoidosa-150 mg
| Panax ginseng L. (Korean Ginseng) Root-50 mg Lecithin - 70 mg Rutin- 50 mg Taurine-200 mg
|
Softgel Capsule
|
-
|
Northfield Laboratories Inc.
|
Philippines
|
Initial (OTC)
|
17 February 2023
|
29 January 2026
|
| View |
|
DR-XY48631
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 1000 + 10
|
10mg/1g
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48632
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 500 + 10
|
10 mg/500mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48633
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 1000 + 5
|
5mg/1g
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
|
DR-XY48634
|
Dapagliflozin + Metformin Hydrochloride
|
Gliflomet 500 + 5
|
5mg/500mg
|
Film-Coated Tablet
|
-
|
Torrent Pharmaceuticals Ltd.
|
India
|
Monitored Release
|
17 February 2023
|
17 February 2028
|
| View |
DR-XY48635_PI_01.pdf
|
DR-XY48635
|
Bedaquiline (as Fumarate)
|
Sirturo
|
20 mg
|
Tablet
|
-
|
Recipharm Pharmaservices Pvt. Ltd.
|
India
|
Monitored Release
|
23 February 2023
|
23 February 2028
|
| View |
|
DR-XY48636
|
Spherical Carbon Adsorbent
|
Kremezin
|
500 mg
|
Tablet
|
-
|
Sato Yakuhin Kogyo Co., Ltd.
|
Japan
|
DR-XY48636
|
06 March 2023
|
06 March 2028
|
| View |
|
DR-XY48637
|
Rocuronium Bromide
|
Kabiroc
|
10 mg/mL
|
Solution For Injection (IV)
|
-
|
PT. Ethica Industri Farmasi
|
Indonesia
|
Initial
|
23 February 2023
|
23 February 2028
|
| View |
|
DR-XY48638
|
Rivaroxaban
|
None
|
10 mg
|
Film-Coated Tablet
|
-
|
Beker Laboratories
|
Algeria
|
DR-XY48638
|
28 February 2023
|
28 February 2028
|
| View |
|
DR-XY48639
|
Multivitamins + Minerals
|
None
|
Formulation:
Each Effervescent tablet contains:
Thiamine Mononitrate (Vitamin B1) 1.5 mg Riboflavin (Vitamin B2) 1.5 mg
Pyridoxine (Vitamin B6) 1.5 mg
Cyanocobalamin (Vitamin B12) 3 mcg
dl-a-Tocopheryl acetate (Vitamin E)60 IU
Niacinamide 10 mg
Biotin 30 mcg
Calcium D-Pantothenate 5mg
Folic Acid 400 mcg
|
Effervescent Tablet
(Pomelo Flavor)
|
-
|
Yuesheng Biotech Co., Ltd.
|
Taiwan
|
Initial
|
02 March 2023
|
02 March 2028
|
| View |
|
DR-XY48640
|
Docetaxel
|
Brexel 20
|
20 mg/2 mL
|
Solution for IV Injection
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
07 March 2023
|
07 March 2025
|
| View |
|
DR-XY48641
|
Colecalciferol (Vitamin D)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Arizona Nutritional Supplements
|
United States of America
|
Initial (OTC)
|
07 March 2023
|
07 March 2028
|
| View |
DR-XY48642_PI_01.pdf
|
DR-XY48642
|
Bendamustine Hydrochloride
|
Bendared
|
45 mg/mL
|
Concentrate for Solution for IV Infusion.
|
-
|
Dr. Reddy's Laboratories Ltd. (Formulation FTO-7)
|
India
|
DR-XY48642
|
08 March 2023
|
08 March 2028
|
| View |
|
DR-XY48643
|
Ceftazidime (As Pentahydrate)
|
Aetaz
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Shenzhen China Resources Gosun Pharmaceuticals Co., Ltd.
|
China
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DR-XY48644
|
Ketoconazole
|
Kezole
|
20mg/g (2% w/w)
|
Topical Cream
|
-
|
Zee Laboratories Limited
|
India
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DR-XY48645
|
Thiamine Mononitrate (Vitamin B1) + Pyridoxine Hydrochloride (Vitamin B6) + Cyanocobalamin (Vitamin B12)
|
Baulivit-B
|
100 mg/100 mg/100 mcg
|
Capsule
|
-
|
Bauch Phils. Laboratories, Inc.
|
Philippines
|
Initial
|
09 March 2023
|
09 March 2025
|
| View |
|
DR-XY48646
|
Docetaxel
|
Brexel 80
|
10 mg/mL (80 mg/ 8 mL)
|
Solution for Injection for I.V. Infusion
|
-
|
PT. Global Onkolab Farma
|
Indonesia
|
Initial
|
09 March 2023
|
09 March 2028
|
| View |
|
DR-XY48647
|
Erlotinib (as Hydrochloride)
|
Erlox
|
150 mg
|
Film-Coated Tablet
|
-
|
Shandong Confucius Pharmaceutical Co., Ltd.
|
China
|
Initial (Re-application)
|
09 March 2023
|
09 March 2028
|
| View |
|
DR-XY48648
|
Acetylcysteine
|
Fluicin
|
600mg
|
Effervescent Tablet
|
-
|
Millimed Co., Ltd. (Branch)
|
Thailand
|
Initial
|
13 March 2023
|
13 March 2028
|