← FDA DRUG APPROVALS

FDA ANDA · ANDA071609

DOXEPIN HYDROCHLORIDE

Sponsor: TEVA PHARMS

APPLICATION
ANDA071609
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-09
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML · CONCENTRATE · ORAL

Approval history

2014-07-17Labeling · Supplement 28 · standard — Label ↗AP
2007-10-29Labeling · Supplement 25AP
2007-07-09Labeling · Supplement 24AP
2006-05-23Labeling · Supplement 23AP
2005-07-08Labeling · Supplement 22AP
2002-03-13Labeling · Supplement 18AP
2002-02-27Manufacturing (CMC) · Supplement 17AP
2002-02-27Manufacturing (CMC) · Supplement 16AP
2002-01-23Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 15AP
2001-10-31Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 14AP
2001-02-26Manufacturing (CMC) · Supplement 11AP
1999-06-17Manufacturing (CMC) · Supplement 10AP
1999-03-23Manufacturing (CMC) · Supplement 9AP
1998-06-11Manufacturing (CMC) · Supplement 8AP
1997-11-13Manufacturing (CMC) · Supplement 7AP
1996-05-31Manufacturing (CMC) · Supplement 6AP
1993-07-12Labeling · Supplement 5AP
1993-05-27Manufacturing (CMC) · Supplement 4AP
1992-09-29Manufacturing (CMC) · Supplement 3AP
1992-09-29Manufacturing (CMC) · Supplement 2AP
1990-11-07Labeling · Supplement 1AP
1987-11-09OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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