Details for New Drug Application (NDA): 219559
NDA 219559 describes FIDAXOMICIN, which is a drug marketed by Actavis Labs Fl, Apotex, Hikma, Sandoz, and Torrent, and is included in five NDAs. It is available from five suppliers. Additional details are available on the FIDAXOMICIN profile page.
The generic ingredient in FIDAXOMICIN is fidaxomicin. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
The generic ingredient in FIDAXOMICIN is fidaxomicin. There is one drug master file entry for this compound. Six 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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