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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 090446

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NDA 090446 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, Rising, 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 thirty 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 090446

Tradename:	NIACIN
Applicant:	Chartwell Rx
Ingredient:	niacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 090446

Hypolipidemic Agents
Vasodilator Agents
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Mar 20, 2014	TE:	AB	RLD:	No

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