APPLICATION
NDA017658
TYPE
NDA
ORIGINAL APPROVAL
1976-05-04
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
LOXITANE CDiscontinued
LOXAPINE HYDROCHLORIDE EQ 25MG BASE/ML · CONCENTRATE · ORAL
Approval history
2000-10-10Manufacturing (CMC) · Supplement 36 · standardAP
2000-09-26Manufacturing (CMC) · Supplement 37 · standardAP
1998-09-16Labeling · Supplement 35 · standardAP
1998-01-28Manufacturing (CMC) · Supplement 34 · standardAP
1997-08-28Manufacturing (CMC) · Supplement 33 · standardAP
1994-11-21Manufacturing (CMC) · Supplement 32 · standardAP
1994-06-29Manufacturing (CMC) · Supplement 31 · standardAP
1994-03-29Manufacturing (CMC) · Supplement 30 · standardAP
1990-07-16Manufacturing (CMC) · Supplement 29 · standardAP
1987-02-03Manufacturing (CMC) · Supplement 25 · standardAP
1984-11-30Manufacturing (CMC) · Supplement 21 · standardAP
1983-10-17Manufacturing (CMC) · Supplement 17 · standardAP
1983-03-10Labeling · Supplement 18AP
1982-09-13Manufacturing (CMC) · Supplement 16 · standardAP
1981-10-08Labeling · Supplement 12AP
1981-05-26Manufacturing (CMC) · Supplement 15 · standardAP
1981-05-14Manufacturing (CMC) · Supplement 13 · standardAP
1981-04-03Manufacturing (CMC) · Supplement 14 · standardAP
1981-01-06Manufacturing (CMC) · Supplement 11 · standardAP
1980-09-16Manufacturing (CMC) · Supplement 9 · standardAP
1979-09-24Labeling · Supplement 10AP
1977-10-11Labeling · Supplement 7AP
1977-06-03Manufacturing (CMC) · Supplement 6 · standardAP
1977-04-21Manufacturing (CMC) · Supplement 4 · standardAP
1977-04-21Manufacturing (CMC) · Supplement 3 · standardAP
1976-05-04Type 2 - New Active Ingredient · 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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