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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 204934

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NDA 204934 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 204934

Tradename:	NIACIN
Applicant:	Macleods Pharms Ltd
Ingredient:	niacin
Patents:	0

Pharmacology for NDA: 204934

Medical Subject Heading (MeSH) Categories for 204934

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

Suppliers and Packaging for NDA: 204934

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	204934	ANDA	Macleods Pharmaceuticals Limited	33342-187	33342-187-10	90 TABLET in 1 BOTTLE (33342-187-10)
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	204934	ANDA	Macleods Pharmaceuticals Limited	33342-187	33342-187-11	100 TABLET in 1 BOTTLE (33342-187-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Mar 3, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Mar 3, 2022	TE:	AB	RLD:	No

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