APPLICATION
NDA016987
TYPE
NDA
ORIGINAL APPROVAL
1972-01-31
LATEST ACTION
1990-06-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 150MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 100MG BASE · CAPSULE · ORAL
DOXEPIN HYDROCHLORIDEDiscontinued
DOXEPIN HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL
Approval history
1990-06-19Manufacturing (CMC) · Supplement 44 · standardAP
1988-10-13Labeling · Supplement 42AP
1988-01-22Labeling · Supplement 37AP
1987-11-05Manufacturing (CMC) · Supplement 35 · standardAP
1987-11-03Manufacturing (CMC) · Supplement 38 · standardAP
1987-11-03Manufacturing (CMC) · Supplement 39 · standardAP
1987-04-13Manufacturing (CMC) · Supplement 18 · standardAP
1986-11-06Labeling · Supplement 36AP
1986-10-20Manufacturing (CMC) · Supplement 32 · standardAP
1986-06-16Manufacturing (CMC) · Supplement 34 · standardAP
1986-03-19Manufacturing (CMC) · Supplement 33 · standardAP
1985-11-21Labeling · Supplement 29AP
1985-03-29Manufacturing (CMC) · Supplement 25 · standardAP
1985-01-22Labeling · Supplement 31AP
1984-08-24Manufacturing (CMC) · Supplement 28 · standardAP
1984-08-22Manufacturing (CMC) · Supplement 27 · standardAP
1984-04-11Labeling · Supplement 26AP
1983-09-19Manufacturing (CMC) · Supplement 23 · standardAP
1983-09-19Manufacturing (CMC) · Supplement 24 · standardAP
1983-04-25Manufacturing (CMC) · Supplement 22 · standardAP
1980-04-15Labeling · Supplement 16AP
1980-01-15Manufacturing (CMC) · Supplement 15 · standardAP
1978-06-08Manufacturing (CMC) · Supplement 14 · standardAP
1977-12-12Manufacturing (CMC) · Supplement 11 · standardAP
1977-09-15Labeling · Supplement 13AP
1975-04-28Efficacy · Supplement 10AP
1972-01-31Type 5 - New Formulation or New Manufacturer · 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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