← FDA DRUG APPROVALS

FDA NDA · NDA022036

SILENOR

doxepin hydrochloride

Sponsor: CURRAX

APPLICATION
NDA022036
TYPE
NDA
ORIGINAL APPROVAL
2010-03-17
LATEST ACTION
2020-10-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SILENOR · ReferencePrescription
DOXEPIN HYDROCHLORIDE EQ 3MG BASE · TABLET · ORAL
SILENOR · ReferencePrescription
DOXEPIN HYDROCHLORIDE EQ 6MG BASE · TABLET · ORAL

Approval history

2020-10-29Labeling · Supplement 6 · standard — Label ↗AP
2016-12-22Manufacturing (CMC) · Supplement 4 · standardAP
2014-08-08Manufacturing (CMC) · Supplement 3 · standardAP
2011-10-30REMS · Supplement 1 — Letter ↗AP
2010-03-17Type 3 - New Dosage Form · Original · standard — Summary Review ↗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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