Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074217
Company: WATSON LABS

Products on ANDA 074217

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 074217

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/27/1994	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
09/15/2025	SUPPL-29	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/10/2015	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
03/18/2013	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
05/09/2008	SUPPL-19	Labeling		Label is not available on this site.
04/28/2008	SUPPL-18	Labeling		Label is not available on this site.
11/07/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
06/12/2002	SUPPL-7	Manufacturing (CMC)-Facility		Label is not available on this site.
06/12/2002	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
09/05/2001	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
10/23/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
02/25/2000	SUPPL-3	Labeling		Label is not available on this site.
11/10/1999	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/20/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.