APPLICATION
ANDA064139
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-29
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
AMOXICILLINDiscontinued
AMOXICILLIN 125MG · TABLET, CHEWABLE · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 250MG · TABLET, CHEWABLE · ORAL
Approval history
2024-05-01Labeling · Supplement 16 · standardAP
2024-04-25Labeling · Supplement 15 · standardAP
2024-04-25Labeling · Supplement 13 · standardAP
2024-04-25Labeling · Supplement 14 · standardAP
2001-11-30Labeling · Supplement 11AP
2001-07-13Labeling · Supplement 10AP
2001-03-12Labeling · Supplement 9AP
2000-11-27Labeling · Supplement 8AP
1999-11-17Labeling · Supplement 7AP
1999-06-09Manufacturing (CMC) · Supplement 4AP
1999-01-25Labeling · Supplement 5AP
1997-11-05Manufacturing (CMC) · Supplement 3AP
1997-01-13Manufacturing (CMC) · Supplement 1AP
1997-01-13Labeling · Supplement 2AP
1996-01-29OriginalAP
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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