APPLICATION
ANDA071238
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-30
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2014-07-17Labeling · Supplement 26 · standardAP
2012-01-26Labeling · Supplement 18AP
2008-03-17Labeling · Supplement 22AP
2007-07-02Labeling · Supplement 19AP
2004-04-14Labeling · Supplement 16AP
2001-04-25Manufacturing (CMC) · Supplement 15AP
2000-12-15Labeling · Supplement 14AP
1997-12-16Manufacturing (CMC) · Supplement 12AP
1995-12-19Labeling · Supplement 11AP
1993-08-27Labeling · Supplement 10AP
1991-05-31Manufacturing (CMC) · Supplement 7AP
1991-05-22Labeling · Supplement 9AP
1990-11-19Manufacturing (CMC) · Supplement 8AP
1990-06-29Manufacturing (CMC) · Supplement 6AP
1988-06-03Manufacturing (CMC) · Supplement 4AP
1988-06-03Manufacturing (CMC) · Supplement 5AP
1987-11-06Manufacturing (CMC) · Supplement 2AP
1987-11-06Manufacturing (CMC) · Supplement 1AP
1987-04-30OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.