Details for New Drug Application (NDA): 213820
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NDA 213820 describes NITAZOXANIDE, which is a drug marketed by Rising and is included in one NDA. It is available from one supplier. 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. One supplier is 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. One supplier is 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 Pharmaceuticals, Inc. | 64980-526 | 64980-526-03 | 30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03) |
| NITAZOXANIDE | nitazoxanide | TABLET;ORAL | 213820 | ANDA | Rising Pharmaceuticals, 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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