APPLICATION
ANDA076868
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-04
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LOXAPINE SUCCINATEPrescription
LOXAPINE SUCCINATE EQ 25MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEPrescription
LOXAPINE SUCCINATE EQ 5MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEPrescription
LOXAPINE SUCCINATE EQ 50MG BASE · CAPSULE · ORAL
LOXAPINE SUCCINATEPrescription
LOXAPINE SUCCINATE EQ 10MG BASE · CAPSULE · ORAL
Approval history
2025-01-22Labeling · Supplement 12 · standardAP
2017-02-23Labeling · Supplement 9 · standardAP
2015-04-29Labeling · Supplement 8AP
2008-11-19Labeling · Supplement 7AP
2008-09-08Labeling · Supplement 6AP
2005-08-04OriginalAP
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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