Details for New Drug Application (NDA): 209810
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NDA 209810 describes APIXABAN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Bionpharma, Breckenridge, Hetero Labs Ltd V, Impax, Macleods Pharms Ltd, Micro Labs, Mylan, Regcon Holdings, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from three suppliers. 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Pharmacology for NDA: 209810
| Mechanism of Action | Factor Xa Inhibitors |
Suppliers and Packaging for NDA: 209810
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| APIXABAN | apixaban | TABLET;ORAL | 209810 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1721 | 0115-1721-01 | 10 BLISTER PACK in 1 CARTON (0115-1721-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1721-15) |
| APIXABAN | apixaban | TABLET;ORAL | 209810 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1721 | 0115-1721-03 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Feb 14, 2025 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 14, 2025 | TE: | RLD: | No | |||||
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