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Last Updated: September 25, 2020

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Details for New Drug Application (NDA): 081134

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NDA 081134 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Jubilant Generics, Lannett Co Inc, Lupin Ltd, Mylan, 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-seven NDAs. It is available from nine 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. Ten suppliers are listed for this compound. Additional details are available on the niacin profile page.
Summary for 081134
Tradename:NIACIN
Applicant:Wockhardt
Ingredient:niacin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 081134

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 28, 1992TE:AARLD:No

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