Last Updated: November 8, 2026

Details for New Drug Application (NDA): 204178

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NDA 204178 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 204178

Tradename:	NIACIN
Applicant:	Amneal Pharms
Ingredient:	niacin
Patents:	0

Pharmacology for NDA: 204178

Medical Subject Heading (MeSH) Categories for 204178

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

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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