Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074141
Company: HERITAGE PHARMA

Products on ANDA 074141

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL TARTRATE	METOPROLOL TARTRATE	50MG	TABLET;ORAL	Discontinued	None	No	No
METOPROLOL TARTRATE	METOPROLOL TARTRATE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074141

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/31/1995	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
07/31/2015	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
03/18/2013	SUPPL-34	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
03/11/2010	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
03/30/2010	SUPPL-32	Labeling-Package Insert		Label is not available on this site.
03/26/2002	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/22/2002	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/02/2001	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
04/18/2000	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/1999	SUPPL-18	Labeling		Label is not available on this site.
12/02/1999	SUPPL-17	Manufacturing (CMC)-Facility		Label is not available on this site.
12/02/1999	SUPPL-16	Manufacturing (CMC)-Facility		Label is not available on this site.
02/12/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
02/12/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/07/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/29/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/19/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/14/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
08/16/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/18/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.