APPLICATION
ANDA062884
TYPE
ANDA
ORIGINAL APPROVAL
1988-02-25
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AMOXICILLINDiscontinued
AMOXICILLIN 250MG · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 26 · standardAP
2024-04-25Labeling · Supplement 25 · standardAP
2024-04-25Labeling · Supplement 23 · standardAP
2024-04-25Labeling · Supplement 24 · standardAP
2001-11-30Labeling · Supplement 16AP
2001-07-13Labeling · Supplement 15AP
2001-03-12Labeling · Supplement 14AP
2000-11-27Labeling · Supplement 13AP
1999-11-17Labeling · Supplement 11AP
1999-06-09Manufacturing (CMC) · Supplement 9AP
1999-04-13Manufacturing (CMC) · Supplement 8AP
1999-01-25Labeling · Supplement 10AP
1994-07-01Labeling · Supplement 7AP
1993-09-29Manufacturing (CMC) · Supplement 5AP
1992-11-30Manufacturing (CMC) · Supplement 4AP
1992-03-18Labeling · Supplement 3AP
1991-11-20Manufacturing (CMC) · Supplement 1AP
1991-11-20Manufacturing (CMC) · Supplement 2AP
1988-02-25OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.