APPLICATION
ANDA062216
TYPE
ANDA
ORIGINAL APPROVAL
1979-08-02
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMOXILPrescription
AMOXICILLIN 250MG · CAPSULE · ORAL
AMOXILPrescription
AMOXICILLIN 500MG · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 44 · standardAP
2017-05-18Labeling · Supplement 38 · standardAP
2014-12-05Labeling · Supplement 34AP
2014-11-17Labeling · Supplement 36AP
2009-03-12Labeling · Supplement 33AP
2009-03-06Labeling · Supplement 32AP
2009-02-17Labeling · Supplement 31AP
2005-09-01Labeling · Supplement 30AP
2004-10-07Labeling · Supplement 29AP
2002-12-09Manufacturing (CMC) · Supplement 28AP
2001-08-22Labeling · Supplement 27AP
2001-05-31Manufacturing (CMC) · Supplement 26AP
1999-06-08Labeling · Supplement 23AP
1998-08-04Labeling · Supplement 18AP
1998-08-04Labeling · Supplement 12AP
1998-04-20Manufacturing (CMC) · Supplement 20AP
1996-04-24Labeling · Supplement 13AP
1996-03-19Manufacturing (CMC) · Supplement 19AP
1995-05-22Labeling · Supplement 15AP
1994-05-16Manufacturing (CMC) · Supplement 16AP
1994-03-31Manufacturing (CMC) · Supplement 11AP
1993-04-19Labeling · Supplement 14AP
1979-08-02OriginalAP
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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