APPLICATION
ANDA071437
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-09
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
2014-07-17Labeling · Supplement 35 · standardAP
2007-12-12Labeling · Supplement 33AP
2007-06-25Labeling · Supplement 32AP
2006-01-30Labeling · Supplement 29AP
2005-09-30Labeling · Supplement 26AP
2005-08-03Labeling · Supplement 25AP
2005-07-07Labeling · Supplement 24AP
2000-10-31Labeling · Supplement 21AP
1999-02-16Manufacturing (CMC) · Supplement 20AP
1998-06-01Manufacturing (CMC) · Supplement 19AP
1998-06-01Manufacturing (CMC) · Supplement 18AP
1997-11-26Manufacturing (CMC) · Supplement 17AP
1997-11-26Manufacturing (CMC) · Supplement 16AP
1995-11-21Labeling · Supplement 15AP
1994-08-25Manufacturing (CMC) · Supplement 14AP
1994-08-09Manufacturing (CMC) · Supplement 12AP
1993-11-08Labeling · Supplement 13AP
1989-06-28Labeling · Supplement 11AP
1989-04-03Labeling · Supplement 10AP
1989-03-15Labeling · Supplement 9AP
1988-05-12Labeling · Supplement 7AP
1988-04-19Labeling · Supplement 6AP
1988-03-30Manufacturing (CMC) · Supplement 2AP
1988-03-30Labeling · Supplement 5AP
1988-03-30Manufacturing (CMC) · Supplement 1AP
1987-11-09OriginalAP
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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