Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072419
Company: WATSON PHARMS TEVA

Products on ANDA 072419

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072419

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/1989	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
07/17/2014	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
07/24/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
10/05/2001	SUPPL-12	Labeling		Label is not available on this site.
09/05/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
11/10/1999	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/01/1997	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/27/1995	SUPPL-8	Labeling		Label is not available on this site.
05/04/1995	SUPPL-7	Labeling		Label is not available on this site.
10/08/1993	SUPPL-6	Labeling		Label is not available on this site.
10/08/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/02/1992	SUPPL-4	Labeling		Label is not available on this site.
01/17/1991	SUPPL-3	Labeling		Label is not available on this site.
01/07/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/12/1989	SUPPL-1	Labeling		Label is not available on this site.