Details for New Drug Application (NDA): 200484

NDA 200484 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 200484

Tradename:	NIACIN
Applicant:	Sun Pharm
Ingredient:	niacin
Patents:	0

Pharmacology for NDA: 200484

Medical Subject Heading (MeSH) Categories for 200484

Hypolipidemic Agents

Vasodilator Agents

Vitamin B Complex

Suppliers and Packaging for NDA: 200484

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	200484	ANDA	Sun Pharmaceutical Industries, Inc.	47335-539	47335-539-08	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-08)
NIACIN	niacin	TABLET, EXTENDED RELEASE;ORAL	200484	ANDA	Sun Pharmaceutical Industries, Inc.	47335-539	47335-539-18	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-539-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	500MG
Approval Date:	Apr 23, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	1GM
Approval Date:	Apr 23, 2014	TE:	AB	RLD:	No

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