APPLICATION
ANDA074721
TYPE
ANDA
ORIGINAL APPROVAL
1998-12-29
LATEST ACTION
2014-07-17
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML · CONCENTRATE · ORAL
Approval history
2014-07-17Labeling · Supplement 11 · standardAP
2008-07-14Labeling · Supplement 9AP
2007-06-26Labeling · Supplement 8AP
2006-06-05Labeling · Supplement 7AP
2005-08-15Labeling · Supplement 6AP
2002-04-30Manufacturing (CMC) · Supplement 3AP
2000-08-30Labeling · Supplement 2AP
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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