APPLICATION
ANDA202510
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-24
LATEST ACTION
2023-09-22
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
2023-09-22Labeling · Supplement 2 · standardAP
2023-09-22Labeling · Supplement 1 · standardAP
2020-07-24UNKNOWN · 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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