Last Updated: November 8, 2026

Details for New Drug Application (NDA): 083453

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NDA 083453 describes NIACIN, which is a drug marketed by Adaptis, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Jubilant Generics, Macleods Pharms, Mpp Pharma, Quagen, Rising, Sun Pharm, Yichang Humanwell, Zydus Pharms, Everylife, Halsey, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mk Labs, Purepac Pharm, Sandoz, Tablicaps, Watson Labs, and Wockhardt, and is included in thirty-two NDAs. It is available from nine suppliers. Additional details are available on the NIACIN profile page.

The generic ingredient in NIACIN is niacin. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the niacin profile page.

Summary for 083453

Tradename:	NIACIN
Applicant:	Halsey
Ingredient:	niacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 083453

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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