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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076250
Company: BARR

Products on ANDA 076250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2005	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076250ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076250_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/10/2013	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/20/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076250

NIACIN

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203578	AMNEAL PHARMS
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209236	AUROBINDO PHARMA LTD
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076250	BARR
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090446	CHARTWELL RX
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213090	EYWA
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203899	LANNETT CO INC
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204934	MACLEODS PHARMS LTD
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200484	SUN PHARM

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