FDA ANDA · ANDA215076
DOXEPIN HYDROCHLORIDE
Sponsor: ALEMBIC
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APPLICATION
ANDA215076
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-21
LATEST ACTION
2026-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
2026-09-30Labeling · Supplement 9 · standardAP
2021-04-21UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →