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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072691
Company: WATSON LABS

Products on ANDA 072691

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXAPINE	AMOXAPINE	150MG	TABLET;ORAL	Prescription	None	No	Yes
AMOXAPINE	AMOXAPINE	25MG	TABLET;ORAL	Prescription	None	No	No
AMOXAPINE	AMOXAPINE	50MG	TABLET;ORAL	Prescription	None	No	No
AMOXAPINE	AMOXAPINE	100MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072691

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/28/1992	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-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072691s036lbl.pdf
04/14/2008	SUPPL-19	Labeling		Label is not available on this site.
07/03/2007	SUPPL-17	Labeling		Label is not available on this site.
05/05/2005	SUPPL-13	Labeling		Label is not available on this site.
05/07/2002	SUPPL-10	Labeling		Label is not available on this site.
10/23/2002	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
02/14/2001	SUPPL-8	Labeling		Label is not available on this site.
04/25/2001	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
12/13/1995	SUPPL-4	Labeling		Label is not available on this site.
02/07/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/19/1993	SUPPL-2	Labeling		Label is not available on this site.
02/05/1993	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 072691

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/17/2014	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/072691s036lbl.pdf

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