Details for New Drug Application (NDA): 219559
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NDA 219559 describes FIDAXOMICIN, which is a drug marketed by Actavis Labs Fl, Apotex, and Torrent, and is included in three NDAs. It is available from three suppliers. Additional details are available on the FIDAXOMICIN profile page.
The generic ingredient in FIDAXOMICIN is fidaxomicin. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
The generic ingredient in FIDAXOMICIN is fidaxomicin. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
Summary for 219559
| Tradename: | FIDAXOMICIN |
| Applicant: | Apotex |
| Ingredient: | fidaxomicin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219559
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIDAXOMICIN | fidaxomicin | TABLET;ORAL | 219559 | ANDA | Apotex Corp. | 60505-4833 | 60505-4833-2 | 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Feb 2, 2026 | TE: | AB | RLD: | No | ||||
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