APPLICATION
ANDA210675
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-16
LATEST ACTION
2024-08-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
2024-08-27Labeling · Supplement 4 · standardAP
2024-08-27Labeling · Supplement 3 · standardAP
2020-10-21UNKNOWN · Supplement 1 · standardAP
2020-10-16UNKNOWN · Original · standardAP
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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