Details for New Drug Application (NDA): 208443
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NDA 208443 describes FIDAXOMICIN, which is a drug marketed by Actavis Labs Fl and is included in one NDA. It is available from one supplier. 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. Two 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. Two suppliers are listed for this compound. Additional details are available on the fidaxomicin profile page.
Summary for 208443
| Tradename: | FIDAXOMICIN |
| Applicant: | Actavis Labs Fl |
| Ingredient: | fidaxomicin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208443
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FIDAXOMICIN | fidaxomicin | TABLET;ORAL | 208443 | ANDA | Teva Pharmaceuticals, Inc. | 0480-2596 | 0480-2596-34 | 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 16, 2024 | TE: | AB | RLD: | No | ||||
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