Details for New Drug Application (NDA): 213820
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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: | RLD: | No |
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