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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204934
Company: MACLEODS PHARMS LTD

Products on ANDA 204934

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/2022	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2025	SUPPL-3	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/07/2023	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204934

NIACIN

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203578	AMNEAL PHARMS
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	209236	AUROBINDO PHARMA LTD
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076378	BARR
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090860	CHARTWELL RX
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213090	HIBROW HLTHCARE
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203899	LANNETT CO INC
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204934	MACLEODS PHARMS LTD
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	207726	MPP PHARMA
NIACIN	NIACIN	500MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200484	SUN PHARM

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	HIBROW HLTHCARE
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	207726	MPP PHARMA
NIACIN	NIACIN	1GM	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200484	SUN PHARM

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