APPLICATION
ANDA064076
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-30
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 250MG · CAPSULE · ORAL
AMOXICILLINPrescription
AMOXICILLIN 500MG · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 38 · standardAP
2024-04-25Labeling · Supplement 37 · standardAP
2020-06-03Labeling · Supplement 31 · standardAP
2020-06-03Labeling · Supplement 30 · standardAP
2014-11-25Labeling · Supplement 27 · standardAP
2013-02-22Labeling · Supplement 25 · standardAP
2007-05-31Labeling · Supplement 17AP
2007-05-31Labeling · Supplement 18AP
2006-05-10Labeling · Supplement 16AP
2005-09-09Labeling · Supplement 14AP
2004-09-30Labeling · Supplement 11AP
2004-09-30Labeling · Supplement 12AP
2004-04-06Labeling · Supplement 10AP
2001-04-12Manufacturing (CMC) · Supplement 7AP
2000-12-21Manufacturing (CMC) · Supplement 6AP
2000-08-07Manufacturing (CMC) · Supplement 5AP
1997-04-14Manufacturing (CMC) · Supplement 4AP
1996-11-08Manufacturing (CMC) · Supplement 3AP
1996-11-08Manufacturing (CMC) · Supplement 1AP
1994-09-30OriginalAP
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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