APPLICATION
ANDA072879
TYPE
ANDA
ORIGINAL APPROVAL
1991-06-28
LATEST ACTION
2024-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXAPINEPrescription
AMOXAPINE 100MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 25MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 50MG · TABLET · ORAL
AMOXAPINEPrescription
AMOXAPINE 150MG · TABLET · ORAL
Approval history
2024-05-29Labeling · Supplement 15 · standardAP
2014-07-17Labeling · Supplement 14 · standardAP
2002-03-25Manufacturing (CMC) · Supplement 10AP
2001-05-22Labeling · Supplement 9AP
2001-03-23Manufacturing (CMC) · Supplement 8AP
2000-09-18Manufacturing (CMC) · Supplement 7AP
1999-05-05Manufacturing (CMC) · Supplement 6AP
1997-09-17Manufacturing (CMC) · Supplement 5AP
1995-04-10Labeling · Supplement 4AP
1994-01-24Manufacturing (CMC) · Supplement 3AP
1993-07-29Labeling · Supplement 2AP
1991-06-28OriginalAP
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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