| View |
|
DR-XY48875
|
Ketorolac Tromethamine
|
Ketoropors
|
300 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Med Biopharm Pvt. Ltd.
|
India
|
Initial
|
04 December 2023
|
12 September 2028
|
| View |
|
DR-XY48876
|
Abiraterone Acetate
|
Arabitro
|
250 mg
|
Tablet
|
-
|
Glenmark Pharmaceuticals Limited
|
India
|
Monitored Release (MR) (Re-application)
|
09 November 2023
|
09 November 2028
|
| View |
|
DR-XY48877
|
Ledipasvir + Sofosbuvir
|
Ledihep
|
90 mg/400 mg
|
Film-Coated Tablet
|
-
|
Cadila Healthcare Limited
|
India
|
Monitored Release (Re-application)
|
08 September 2023
|
08 September 2026
|
| View |
|
DR-XY48878
|
Quetiapine (as fumarate)
|
Victus XR
|
200 mg
|
Sustained-Release Tablet
|
-
|
Intas Pharmaceuticals Limited.
|
India
|
Initial (Re-application)
|
08 September 2023
|
08 September 2028
|
| View |
|
DR-XY48879
|
Atropine (as sulfate)
|
None
|
1 mg/mL
|
Solution for Injection (IM/IV/SC)
|
-
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial (Re-application)
|
08 September 2023
|
08 September 2028
|
| View |
|
DR-XY48880
|
Ascorbic Acid + Zinc
|
Hero-C+
|
500 mg (equivalent to 562.54 mg Sodium Ascorbate) / 10 mg (equivalent to 27.5 mg Zinc Sulfate Monohydrate)
|
Capsules
|
-
|
Pharmatechnica Laboratory, Inc.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DR-XY48881
|
Ascorbic Acid + Zinc
|
ewel-Zee Plus
|
500 mg (equivalent to 562.50 mg Sodium Ascorbate) / 40
mg (equivalent to 110 mg Zinc Sulfate Monohydrate)
|
Capsule
|
-
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DR-XY48882
|
Ascorbic Acid + Zinc
|
Klin-C
|
500 mg/ 40 mg
|
Capsule
|
-
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DR-XY48883
|
Ascorbic Acid
|
True-Cee Premium
|
578 mg (equivalent to 650 mg Sodium Ascorbate)
|
Capsule
|
-
|
Ashford Pharmaceutical Laboratories, Inc.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2028
|
| View |
|
DR-XY48884
|
Ascorbic Acid + Zinc
|
Maxcee Plus
|
100 mg 10 mg (equivalent to 27.5 mg Zinc Sulfate. Monohydrate) per 5 mL
|
Syrup
|
-
|
Lejal Laboratories, Inc.
|
Philippines
|
Initial
|
13 September 2023
|
13 September 2026
|
| View |
|
DR-XY48885
|
Colecalciferol (Vitamin D3)
|
Forti-D 1000
|
1000 IU
|
Softgel Capsule
|
-
|
Softgel Healthcare Pvt. Ltd.
|
India
|
Initial [OTC]
|
15 September 2023
|
15 September 2028
|
| View |
|
DR-XY48886
|
Ceftriaxone (as sodium)
|
Bactricef
|
1 g
|
Powder for Injection (IM/IV)
|
-
|
Reyoung Pharmaceutical Co., Ltd.
|
China
|
Initial (Correction)
|
08 January 2024
|
15 September 2028
|
| View |
|
DR-XY48887
|
Ephedrine hydrochloride
|
Epidrex
|
30 mg/mL
|
Solution for Injection (IM/IV)
|
-
|
Pharmaniaga Lifesciences Sdn. Bhd
|
Malaysia
|
Initial
|
28 September 2023
|
28 September 2028
|
| View |
|
DR-XY48888
|
Nystatin
|
Nystor
|
100,000 units/Ointment
|
Ointment
|
-
|
TORRENT PHARMACEUTICALS LTD.
|
India
|
Monitored Release
|
02 October 2023
|
02 October 2028
|
| View |
|
DR-XY48889
|
Fulvestrant
|
Dimere
|
250 mg/5 mL
|
Solution For Injection (I.M.)
|
-
|
Laboratorio Kemex S.A
|
Argentina
|
Initial
|
02 October 2023
|
02 October 2028
|
| View |
|
DR-XY48890
|
Ascorbic Acid
|
Saicorvic
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Anhui Hongye Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 October 2023
|
02 October 2028
|
| View |
|
DR-XY48891
|
Ascorbic Acid
|
None
|
250 mg/mL (500 mg/2 mL)
|
Solution for Injection
(IM/IV)
|
-
|
Anhui Hongye Pharmaceutical Co., Ltd.
|
China
|
Initial
|
02 October 2023
|
02 October 2028
|
| View |
|
DR-XY48892
|
Furosemide
|
Furmid
|
10 mg/mL (20 mg / 2 mL)
|
Solution for Injection (I.M./I.V.)
|
-
|
Global Pharmaceuticals (Pvt) Ltd.
|
Pakistan
|
Initial
|
03 October 2023
|
03 October 2028
|
| View |
|
DR-XY48893
|
Hyoscine-N-Butylbromide
|
Sapaspan
|
20 mg/mL
|
Solution for Injection (I.M./I.V./S.C.)
|
-
|
Global Pharmaceuticals (Pvt) Ltd.
|
Pakistan
|
Initial
|
03 October 2023
|
03 October 2028
|
| View |
|
DR-XY48894
|
Fusidic Acid
|
Phusilan
|
20 mg/g (2% w/w)
|
Cream
|
-
|
Global Pharmaceuticals (Pvt) Ltd.
|
Pakistan
|
Initial
|
03 October 2023
|
03 October 2028
|