APPLICATION
ANDA201951
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-26
LATEST ACTION
2024-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 6MG BASE · TABLET · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
Approval history
2024-01-16Labeling · Supplement 10 · standardAP
2020-01-03Manufacturing (CMC) · Supplement 4 · unknownAP
2013-07-26Not Applicable · OriginalAP
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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