← FDA DRUG APPROVALS

FDA ANDA · ANDA207482

DOXEPIN HYDROCHLORIDE

Sponsor: AMNEAL PHARMS CO

APPLICATION
ANDA207482
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-28
LATEST ACTION
2024-07-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEPrescription
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
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

Approval history

2024-07-23Labeling · Supplement 11 · standardAP
2017-06-28UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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