| View |
|
DR-XY49003
|
Hexetidine
|
Vagi-Hex
|
10 mg
|
Vaginal Tablet
|
Antiseptic
|
Artesan Pharma GmbH & Co. KG
|
Germany
|
Initial
|
20 February 2024
|
20 February 2029
|
| View |
|
DR-XY49004
|
Carboprost (as tromethamine)
|
Myoprost
|
250 mcg/mL
|
Solution for Injection (I.M)
|
Uterotonic (Prostaglandin)
|
Ciron Drugs & Pharmaceuticals Pvt. Limited
|
India
|
Initial (Reapplication)
|
21 February 2024
|
21 February 2029
|
| View |
|
DR-XY49005
|
Mycophenolic acid (as Mycophenolate sodium)
|
Mysod
|
360 mg
|
Delayed- Release Tablet
|
Immunosuppressant
|
Panacea Biotec Pharma Ltd.
|
India
|
Initial
|
21 February 2024
|
21 February 2029
|
| View |
|
DR-XY49006
|
Ascorbic Acid + Zinc
|
None
|
500 mg/ 20 mg (equivalent to 562.50 Sodium
ascorbate/54.89 mg Zinc sulfate monohydrate)
|
Capsule
|
Vitamin/Mineral
|
Hizon Laboratories, Inc.
|
Philippines
|
Initial (Correction)
|
13 May 2024
|
22 February 2029
|
| View |
|
DR-XY49007
|
Dapagliflozin
|
Catania
|
10 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug [Sodium-glucose co-
transporter 2 (SGLT2) inhibitor]
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DR-XY49008
|
Dapagliflozin
|
Catania
|
5 mg
|
Film-Coated Tablet
|
Blood glucose lowering drug [Sodium-glucose co-
transporter 2 (SGLT2) inhibitor]
|
Lloyd Laboratories, Inc.
|
Philippines
|
Initial
|
22 February 2024
|
22 February 2029
|
| View |
|
DR-XY49009
|
Nirmatrelvir + Ritonavir
|
Paxlovid
|
150 mg Film-Coated Tablet 100 mg
100 mg Film-Coated Tablet (Co-Packaged)
|
Film-Coated Tablets
|
Antiviral (Protease Inhibitor)
|
Pfizer Italia S.r.l
|
Italy
|
Monitored Release (FRP)
|
22 February 2024
|
22 February 2029
|
| View |
|
DR-XY49010
|
Vortioxetine (as hydrobromide)
|
Brintellix
|
20 mg/mL
|
Solution (Oral Drops)
|
Antidepressant
|
H. Lundbeck A/S
|
Denmark
|
Monitored Release
|
26 February 2024
|
26 February 2029
|
| View |
|
DR-XY49011
|
Docetaxel (as Trihydrate)
|
Docetaze
|
20mg/mL
|
Concentrated Solution for I. V. Infusion
|
Antineoplastic Agent (Taxane)
|
Shilpa Medicare Limited, Unit-4. Formulations Sez
|
India
|
Initial (Reapplication)
|
28 February 2024
|
28 February 2029
|
| View |
|
DR-XY49012
|
Docetaxel (as Trihydrate)
|
Docetaze
|
20mg/mL (80 mg/ 4mL)
|
Concentrated Solution for I.V.
Infusion
|
Antineoplastic Agent (Taxane)
|
Shilpa Medicare Limited, Unit-4 Formulations Sez
|
India
|
Initial (Reapplication)
|
28 February 2024
|
28 February 2029
|
| View |
|
DR-XY49013
|
Cefuroxime (as axetil)
|
Eoroxime-250
|
250 mg/5 mL
|
Powder for Oral Suspension
|
Antibacterial
|
Zee Laboratories Limited
|
India
|
Initial
|
05 March 2024
|
05 March 2029
|
| View |
|
DR-XY49017
|
Febuxostat
|
Febulas 80
|
80 mg
|
Film-Coated Tablet
|
Anti-gout (Preparation Inhibiting Uric Acid Production)
|
Delta Pharma Ltd.
|
Bangladesh
|
Initial
|
26 March 2024
|
26 March 2029
|
| View |
|
DR-XY49018
|
Ascorbic Acid + dl-Alpha Tocopheryl Acetate pha Tocopheryl Acetate (Vitamin E)
|
None
|
500 mg (equivalent to 562.43 mg Sodium Ascorbate) / 12 mg
|
Capsule
|
Vitamins
|
Aldrtz Corporation
|
Philippines
|
Initial
|
12 March 2024
|
12 March 2026
|
| View |
|
DR-XY49019
|
Rivaroxaban
|
Rivaxored
|
10 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Dr. Reddy's Laboratories Limited (FTO Unit 2)
|
India
|
Initial
|
13 March 2024
|
13 March 2029
|
| View |
|
DR-XY49020
|
Rivaroxaban
|
Rivaxored
|
15 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Dr. Reddy's Laboratories Limited (FTO - Unit 2)
|
India
|
Initial
|
13 March 2024
|
13 March 2029
|
| View |
|
DR-XY49021
|
Rivaroxaban
|
Rivaxored
|
20 mg
|
Film-Coated Tablet
|
Antithrombotic Agent (Direct factor Xa inhibitor)
|
Dr. Reddy's Laboratories Limited (FTO - Unit 2)
|
India
|
Initial
|
13 March 2024
|
13 March 2029
|
| View |
|
DR-XY49023
|
Retinol Palmitate (Vitamin A)
|
None
|
100,000 IU
|
Softgel Capsule
|
Vitamins
|
Northfield Laboratories Inc.
|
Philippines
|
Initial
|
21 March 2024
|
21 March 2029
|
| View |
|
DR-XY49024
|
Topotecan (as hydrochloride)
|
Toponova
|
4mg
|
Powder for Concentrate Solution for Infusion
|
Antineoplastic Agent [Topoisomerase 1 (TOP1)
Inhibitor]
|
Venus Remedies, Limited.
|
India
|
Initial
|
22 March 2024
|
22 March 2029
|
| View |
|
DR-XY49025
|
Sterile Water for Injection.
|
none
|
None
|
Sterile Water for Injection
|
Parenteral Diluent
|
Zhejiang Ruixin Pharmaceutical Co. Ltd.
|
China
|
Initial
|
27 March 2024
|
27 March 2029
|
| View |
|
DR-XY49026
|
Ascorbic Acid
|
Asco-C
|
250 mg/mL (500 mg/ 2 mL)
|
Solution for Injection
|
Vitamin
|
Tianjin Kingyork Group Hubei Tianyao Pharmaceutical Co., Ltd.
|
China
|
Initial
|
27 March 2024
|
27 March 2029
|