APPLICATION
ANDA070827
TYPE
ANDA
ORIGINAL APPROVAL
1986-05-15
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
2014-07-17Labeling · Supplement 14 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 10AP
1995-03-13Labeling · Supplement 6AP
1995-03-01Manufacturing (CMC) · Supplement 5AP
1993-08-19Labeling · Supplement 4AP
1991-05-01Manufacturing (CMC) · Supplement 3AP
1989-01-17Labeling · Supplement 2AP
1986-05-15OriginalAP
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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