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FDA NDA · NDA017516

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APPLICATION
NDA017516
TYPE
NDA
ORIGINAL APPROVAL
1974-03-11
LATEST ACTION
2025-07-03
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued

Products

SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL

Approval history

2025-07-03Labeling · Supplement 26 · standard — Letter ↗AP
2014-07-14Labeling · Supplement 25 · 901 required — Label ↗AP
2007-08-02Labeling · Supplement 23 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 22 · standard — Letter ↗AP
2003-09-30Labeling · Supplement 20 · standard — Letter ↗AP
2000-04-10Labeling · Supplement 18 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 15 · standardAP
1989-12-04Manufacturing (CMC) · Supplement 14 · standardAP
1988-03-22Labeling · Supplement 11AP
1984-09-13Labeling · Supplement 10AP
1984-05-01Labeling · Supplement 9AP
1981-11-30Manufacturing (CMC) · Supplement 8 · standardAP
1978-06-08Manufacturing (CMC) · Supplement 7 · standardAP
1976-06-30Manufacturing (CMC) · Supplement 6 · standardAP
1975-03-31REMS · Supplement 3 · standardAP
1974-09-23Manufacturing (CMC) · Supplement 2 · standardAP
1974-03-11Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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