APPLICATION
ANDA072985
TYPE
ANDA
ORIGINAL APPROVAL
1991-03-29
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2014-07-17Labeling · Supplement 17 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 15AP
2001-01-19Labeling · Supplement 16AP
2000-03-21Manufacturing (CMC) · Supplement 13AP
1998-05-18Manufacturing (CMC) · Supplement 12AP
1997-08-19Manufacturing (CMC) · Supplement 10AP
1997-07-08Manufacturing (CMC) · Supplement 9AP
1996-12-31Manufacturing (CMC) · Supplement 6AP
1996-12-31Manufacturing (CMC) · Supplement 5AP
1996-05-16Labeling · Supplement 8AP
1996-04-25Manufacturing (CMC) · Supplement 4AP
1994-07-25Manufacturing (CMC) · Supplement 3AP
1993-08-27Labeling · Supplement 2AP
1991-03-29OriginalAP
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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