Details for New Drug Application (NDA): 220465
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NDA 220465 describes FIDAXOMICIN, which is a drug marketed by Actavis Labs Fl, Apotex, Sandoz, and Torrent, and is included in four NDAs. It is available from four 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
Summary for 220465
| Tradename: | FIDAXOMICIN |
| Applicant: | Sandoz |
| Ingredient: | fidaxomicin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 220465
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIDAXOMICIN | fidaxomicin | TABLET;ORAL | 220465 | ANDA | Sandoz Inc | 0781-5194 | 0781-5194-20 | 20 TABLET, FILM COATED in 1 BOTTLE (0781-5194-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Aug 13, 2026 | TE: | AB | RLD: | No | ||||
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