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Last Updated: October 7, 2022

Details for New Drug Application (NDA): 083180


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NDA 083180 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Macleods Pharms Ltd, Rising, Sun Pharm, Yichang Humanwell, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in twenty-nine NDAs. It is available from ten suppliers. Additional details are available on the NIACIN profile page.

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 083180
Tradename:NIACIN
Applicant:Ivax Sub Teva Pharms
Ingredient:niacin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 083180

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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