Details for New Drug Application (NDA): 209898
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NDA 209898 describes APIXABAN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Indoco, Micro Labs, Mylan, and Zydus Pharms, and is included in ten NDAs. It is available from one supplier. Additional details are available on the APIXABAN profile page.
The generic ingredient in APIXABAN is apixaban. There are thirty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the apixaban profile page.
The generic ingredient in APIXABAN is apixaban. There are thirty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Pharmacology for NDA: 209898
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 209898
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APIXABAN | apixaban | TABLET;ORAL | 209898 | ANDA | Indoco Remedies Limited | 14445-149 | 14445-149-05 | 500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05) |
| APIXABAN | apixaban | TABLET;ORAL | 209898 | ANDA | Indoco Remedies Limited | 14445-149 | 14445-149-10 | 1 TABLET, FILM COATED in 1 CARTON (14445-149-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Sep 11, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 11, 2020 | TE: | AB | RLD: | No | ||||
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