Details for New Drug Application (NDA): 213820
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NDA 213820 describes NITAZOXANIDE, which is a drug marketed by Ani Pharms, Annora Pharma, and Rising, and is included in three 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 213820
| Tradename: | NITAZOXANIDE |
| Applicant: | Rising |
| Ingredient: | nitazoxanide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213820
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 213820 | ANDA | Rising Pharma Holdings, Inc. | 64980-526 | 64980-526-03 | 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) |
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 213820 | ANDA | Rising Pharma Holdings, Inc. | 64980-526 | 64980-526-21 | 12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 27, 2020 | TE: | AB | RLD: | No | ||||
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