APPLICATION
NDA016798
TYPE
NDA
ORIGINAL APPROVAL
1969-09-23
LATEST ACTION
2025-07-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SINEQUAN · ReferenceDiscontinued
DOXEPIN HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2000-04-10Labeling · Supplement 48 · standardAP
2000-03-27Manufacturing (CMC) · Supplement 47 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 44 · standardAP
1990-04-04Manufacturing (CMC) · Supplement 43 · standardAP
1988-10-27Manufacturing (CMC) · Supplement 40 · standardAP
1988-10-27Manufacturing (CMC) · Supplement 39 · standardAP
1987-09-01Manufacturing (CMC) · Supplement 38 · standardAP
1985-10-28Manufacturing (CMC) · Supplement 35 · standardAP
1984-12-11Manufacturing (CMC) · Supplement 33 · standardAP
1984-09-13Labeling · Supplement 34AP
1984-05-10Manufacturing (CMC) · Supplement 32 · standardAP
1984-05-01Labeling · Supplement 31AP
1983-09-26Manufacturing (CMC) · Supplement 30 · standardAP
1983-09-26Manufacturing (CMC) · Supplement 29 · standardAP
1983-07-22Manufacturing (CMC) · Supplement 28 · standardAP
1981-02-12Manufacturing (CMC) · Supplement 27 · standardAP
1980-08-12Manufacturing (CMC) · Supplement 26 · standardAP
1979-10-17Labeling · Supplement 25AP
1978-07-12Manufacturing (CMC) · Supplement 23 · standardAP
1978-07-07Manufacturing (CMC) · Supplement 24 · standardAP
1978-06-06Manufacturing (CMC) · Supplement 22 · standardAP
1978-03-15Labeling · Supplement 20AP
1978-03-15Manufacturing (CMC) · Supplement 19 · standardAP
1977-10-12Manufacturing (CMC) · Supplement 21 · standardAP
1976-10-28Manufacturing (CMC) · Supplement 18 · standardAP
1976-06-04Manufacturing (CMC) · Supplement 16 · standardAP
1976-03-11Manufacturing (CMC) · Supplement 17 · standardAP
1975-06-13Labeling · Supplement 11AP
1975-04-07Manufacturing (CMC) · Supplement 14 · standardAP
1975-03-31Manufacturing (CMC) · Supplement 12 · standardAP
1969-09-23Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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