APPLICATION
ANDA071653
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-18
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 13 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 12AP
1996-05-06Labeling · Supplement 11AP
1995-09-26Labeling · Supplement 10AP
1994-12-23Manufacturing (CMC) · Supplement 9AP
1994-10-11Manufacturing (CMC) · Supplement 8AP
1993-10-01Labeling · Supplement 7AP
1992-04-03Manufacturing (CMC) · Supplement 6AP
1992-04-03Manufacturing (CMC) · Supplement 4AP
1988-02-18OriginalAP
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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