APPLICATION
ANDA072204
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-15
LATEST ACTION
2025-07-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
LOXAPINE SUCCINATEPrescription
LOXAPINE SUCCINATE EQ 5MG BASE · CAPSULE · ORAL
Approval history
2025-07-30Labeling · Supplement 44 · standardAP
2025-01-22Labeling · Supplement 40 · standardAP
2017-02-23Labeling · Supplement 35 · standardAP
2010-12-03Labeling · Supplement 29AP
2009-06-04Labeling · Supplement 28AP
2008-09-08Labeling · Supplement 26AP
2008-09-03Labeling · Supplement 23AP
2002-12-02Labeling · Supplement 12AP
2002-06-17Manufacturing (CMC) · Supplement 13AP
2000-03-29Labeling · Supplement 11AP
2000-03-29Manufacturing (CMC) · Supplement 9AP
2000-01-14Manufacturing (CMC) · Supplement 10AP
1997-11-25Manufacturing (CMC) · Supplement 8AP
1997-02-13Labeling · Supplement 7AP
1992-07-31Labeling · Supplement 6AP
1991-02-01Labeling · Supplement 5AP
1989-04-11Labeling · Supplement 3AP
1988-06-15OriginalAP
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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