APPLICATION
ANDA076762
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-01
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
LOXAPINE SUCCINATEDiscontinued
LOXAPINE SUCCINATE EQ 10MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEDiscontinued
LOXAPINE SUCCINATE EQ 25MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEDiscontinued
LOXAPINE SUCCINATE EQ 5MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEDiscontinued
LOXAPINE SUCCINATE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2025-01-22Labeling · Supplement 14 · standardAP
2017-02-23Labeling · Supplement 11 · standardAP
2010-12-03Labeling · Supplement 9AP
2009-08-18Labeling · Supplement 7AP
2009-04-23Labeling · Supplement 5AP
2008-08-18Labeling · Supplement 4AP
2004-11-01OriginalAP
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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