Details for New Drug Application (NDA): 218701
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NDA 218701 describes NITAZOXANIDE, which is a drug marketed by Ani Pharms, Annora Pharma, and Rising, and is included in three NDAs. It is available from four 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the nitazoxanide profile page.
Summary for 218701
| Tradename: | NITAZOXANIDE |
| Applicant: | Annora Pharma |
| Ingredient: | nitazoxanide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218701
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 218701 | ANDA | Camber Pharmaceuticals, Inc. | 31722-100 | 31722-100-30 | 1 BOTTLE in 1 CARTON (31722-100-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 218701 | ANDA | Camber Pharmaceuticals, Inc. | 31722-100 | 31722-100-31 | 1 BOTTLE in 1 CARTON (31722-100-31) / 12 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 15, 2025 | TE: | AB | RLD: | No | ||||
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