APPLICATION
NDA017525
TYPE
NDA
ORIGINAL APPROVAL
1975-02-25
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, CAPSULE
MARKETING STATUS
Discontinued
Products
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons** · TABLET · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
LOXITANE · ReferenceDiscontinued
LOXAPINE SUCCINATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1998-09-16Labeling · Supplement 49 · standardAP
1997-01-28Manufacturing (CMC) · Supplement 48 · standardAP
1996-03-25Manufacturing (CMC) · Supplement 47 · standardAP
1995-02-27Manufacturing (CMC) · Supplement 46 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 42 · standardAP
1994-03-29Manufacturing (CMC) · Supplement 41 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 43 · standardAP
1990-07-25Manufacturing (CMC) · Supplement 40 · standardAP
1989-07-18Manufacturing (CMC) · Supplement 38 · standardAP
1989-04-28Manufacturing (CMC) · Supplement 37 · standardAP
1987-02-03Manufacturing (CMC) · Supplement 33 · standardAP
1986-05-02Manufacturing (CMC) · Supplement 31 · standardAP
1985-05-14Manufacturing (CMC) · Supplement 29 · standardAP
1983-10-17Manufacturing (CMC) · Supplement 24 · standardAP
1983-04-19Manufacturing (CMC) · Supplement 22 · standardAP
1983-03-10Efficacy · Supplement 21AP
1982-09-13Manufacturing (CMC) · Supplement 23 · standardAP
1981-10-08Labeling · Supplement 20AP
1981-10-08Labeling · Supplement 19AP
1981-01-06Manufacturing (CMC) · Supplement 18 · standardAP
1980-09-16Manufacturing (CMC) · Supplement 15 · standardAP
1979-11-08Manufacturing (CMC) · Supplement 14 · standardAP
1979-04-24Manufacturing (CMC) · Supplement 16 · standardAP
1978-06-08Manufacturing (CMC) · Supplement 13 · standardAP
1978-06-08Manufacturing (CMC) · Supplement 11 · standardAP
1978-01-25Labeling · Supplement 12AP
1977-10-25Labeling · Supplement 8AP
1977-06-03Manufacturing (CMC) · Supplement 2 · standardAP
1976-11-30Manufacturing (CMC) · Supplement 7 · standardAP
1976-08-23Labeling · Supplement 9AP
1976-05-04Manufacturing (CMC) · Supplement 5 · standardAP
1976-05-04Manufacturing (CMC) · Supplement 3 · standardAP
1976-05-04Manufacturing (CMC) · Supplement 4 · standardAP
1975-02-25Type 1 - New Molecular Entity · 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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