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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 204178

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NDA 204178 describes NIACIN, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Beijing, Chartwell Rx, Hibrow Hlthcare, Jubilant Generics, Lannett Co Inc, Macleods Pharms Ltd, Mpp Pharma, 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 eight 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 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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