| View |
|
DR-XY48609
|
Rivaroxaban
|
Xarelto
|
10 mg
|
Film-Coated Tablet
|
-
|
Bayer Bitterfeld GmbH
|
Germany
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48610
|
Letrozole
|
Letrosaph
|
2.5 mg
|
Film-Coated Tablet
|
-
|
Bruck Pharma Private Limited
|
India
|
Initial
|
08 February 2023
|
08 February 2028
|
| View |
|
DR-XY48611
|
Fondaparinux Sodium
|
Fondux
|
2.5 mg/0.5 mL
|
Solution For Injection (IV/SC)
|
Antithrombotic Agent
|
PT Ferron Par Pharmaceuticals
|
Indonesia
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
DR-XY48612_PI_01.pdf
|
DR-XY48612
|
Empagliflozin + Linagliptin
|
Glyxambi
|
25 mg/5 mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
DR-XY48613_PI_01.pdf
|
DR-XY48613
|
Empagliflozin + Linagliptin
|
Glyxambi
|
10 mg/5 mg
|
Film-Coated Tablet
|
-
|
Rottendorf Pharma GmbH
|
Germany
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48614
|
Rimegepant (as sulfate)
|
Nurtec
|
75 mg
|
Orally Disintegrating Tablet
|
-
|
Catalent UK Swindon Zydis Limited
|
United Kingdom
|
Monitored Release
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48615
|
Rosuvastatin (as calcium)
|
Chaletin
|
5 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48616
|
Rosuvastatin (as calcium)
|
Chaletin
|
10 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48617
|
Rosuvastatin (as calcium)
|
Chaletin
|
20 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48618
|
Rosuvastatin (as calcium)
|
Chaletin
|
40 mg
|
Film-Coated Tablet
|
-
|
Changzhou Pharmaceutical Factory
|
China
|
Initial
|
10 February 2023
|
10 February 2028
|
| View |
|
DR-XY48619
|
Nicardipine Hydrochloride
|
Nicafar
|
1mg/mL
|
Solution For IV Infusion
|
-
|
Scott-Edil Pharmacia Limited
|
India
|
Initial
|
15 February 2023
|
15 February 2028
|
| View |
|
DR-XY48620
|
Ipratropium Bromide
|
Ipramide
|
250mcg/mL (500mcg/2mL)
|
Solution for Inhalation
|
-
|
Jewim Pharmaceutical (Shandong) Co., Ltd.
|
China
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48621
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
200 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48622
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48623
|
D-Alpha Tocopherol (Vitamin E)
|
None
|
400 IU
|
Softgel Capsule
|
-
|
Nexgen Pharma Inc.
|
United States of America
|
Initial (OTC)
|
14 February 2023
|
14 February 2028
|
| View |
DR-XY48624_PI_01.pdf
|
DR-XY48624
|
Moxifloxacin (as hydrochloride)
|
Xiflox
|
400mg
|
Film-Coated Tablet
|
-
|
Getz Pharma Pvt. Ltd.
|
Pakistan
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48625
|
Ascorbic Acid + Zinc (as Bisglycinate)
|
None
|
889 mg (equivalent to 1g Sodium Ascorbate)
|
Effervescent Tablet (Grape Flavor)
|
-
|
Yuesheng Biotech Co., Ltd.
|
Taiwan
|
Initial (OTC)
|
15 February 2023
|
15 February 2028
|
| View |
|
DR-XY48626
|
Doxorubicin Hydrochloride
|
None
|
2mg/mL (50mg/25mL)
|
Solution for Injection for I.V.
Infusion
|
-
|
Venus Remedies, Limited
|
India
|
Initial
|
14 February 2023
|
14 February 2028
|
| View |
|
DR-XY48627
|
Multivitamins + Minerals
|
Nutribone
|
Formulation
Each Film-Coated Tablet:
Ascorbic Acid (Vitamin C) 60 mg
Colecalciferol (Vitamin D3) 200 IU
Dl-alpha-Tocopheryl Acetate (Vitamin E) 15 IU
Boron Citrate 250 mcg
Calcium (as Calcium Carbonate) 600 mg
Copper (as Cupric Oxide) 1 mg
Magnesium 20 mg
Manganese (as sulfate monohydrate) 1 mg
Zinc (as Zinc Oxide) 7.5 mg
|
Film-Coated Tablet
|
-
|
The ACME Laboratories Limited
|
Bangladesh
|
Initial
|
28 February 2023
|
28 February 2028
|
| View |
|
DR-XY48628
|
Riboflavin (Vitamin B2)
|
None
|
100mg
|
Capsule
|
-
|
Arizona Nutritional Supplements
|
United States of America
|
Initial (OTC)
|
15 February 2023
|
15 February 2028
|