Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201273
Company: SUN PHARM

Products on ANDA 201273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201273

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2014	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2023	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/02/2023	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/09/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201273

NIACIN

TABLET, EXTENDED RELEASE;ORAL; 750MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204178	AMNEAL PHARMS
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209236	AUROBINDO PHARMA LTD
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076378	BARR
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090892	CHARTWELL RX
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213090	HIBROW HLTHCARE
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207726	MPP PHARMA
NIACIN	NIACIN	750MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201273	SUN PHARM