Details for New Drug Application (NDA): 204178
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The generic ingredient in NIACIN is niacin. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 204178
Tradename: | NIACIN |
Applicant: | Amneal Pharms |
Ingredient: | niacin |
Patents: | 0 |
Suppliers and Packaging for NDA: 204178
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 204178 | ANDA | Amneal Pharmaceuticals LLC | 65162-322 | 65162-322-03 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-03) |
NIACIN | niacin | TABLET, EXTENDED RELEASE;ORAL | 204178 | ANDA | Amneal Pharmaceuticals LLC | 65162-322 | 65162-322-09 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-322-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 750MG | ||||
Approval Date: | Dec 11, 2015 | TE: | AB | RLD: | No |
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