Details for New Drug Application (NDA): 214844
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NDA 214844 describes NITAZOXANIDE, which is a drug marketed by Rising and Zenara and is included in two NDAs. It is available from two suppliers. Additional details are available on the NITAZOXANIDE profile page.
The generic ingredient in NITAZOXANIDE is nitazoxanide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.
The generic ingredient in NITAZOXANIDE is nitazoxanide. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.
Summary for 214844
| Tradename: | NITAZOXANIDE |
| Applicant: | Zenara |
| Ingredient: | nitazoxanide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214844
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 214844 | ANDA | ANI Pharmaceuticals, Inc. | 70954-934 | 70954-934-10 | 6 TABLET in 1 BOTTLE (70954-934-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Feb 3, 2025 | TE: | AB | RLD: | No | ||||
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