APPLICATION
ANDA071918
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-20
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 14 · standardAP
2008-08-13Labeling · Supplement 12AP
2007-06-26Labeling · Supplement 10AP
2001-11-05Labeling · Supplement 8AP
2001-01-11Labeling · Supplement 7AP
1995-08-17Labeling · Supplement 5AP
1995-08-17Labeling · Supplement 6AP
1993-11-24Labeling · Supplement 4AP
1992-02-12Labeling · Supplement 3AP
1991-04-02Labeling · Supplement 2AP
1988-07-20OriginalAP
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.