Details for New Drug Application (NDA): 203899

NDA 203899 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 203899

Tradename:	NIACIN
Applicant:	Lannett Co Inc
Ingredient:	niacin
Patents:	0

Pharmacology for NDA: 203899

Medical Subject Heading (MeSH) Categories for 203899

Hypolipidemic Agents

Vasodilator Agents

Vitamin B Complex

Suppliers and Packaging for NDA: 203899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	203899	ANDA	Golden State Medical Supply, Inc.	51407-267	51407-267-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-267-90)
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	203899	ANDA	Golden State Medical Supply, Inc.	51407-268	51407-268-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-268-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Jun 16, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Jun 16, 2017	TE:	AB	RLD:	No

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