APPLICATION
ANDA064013
TYPE
ANDA
ORIGINAL APPROVAL
1992-12-22
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 250MG · TABLET, CHEWABLE · ORAL
AMOXICILLINPrescription
AMOXICILLIN 125MG · TABLET, CHEWABLE · ORAL
Approval history
2024-05-01Labeling · Supplement 64 · standardAP
2024-01-03Labeling · Supplement 61 · standardAP
2019-12-04Labeling · Supplement 57 · standardAP
2017-05-18Labeling · Supplement 56 · standardAP
2017-05-18Labeling · Supplement 55 · standardAP
2015-09-10Labeling · Supplement 49AP
2009-02-02Labeling · Supplement 45AP
2008-07-17Labeling · Supplement 44AP
2007-05-31Labeling · Supplement 41AP
2003-08-29Labeling · Supplement 36AP
2002-12-09Manufacturing (CMC) · Supplement 32AP
2002-09-10Manufacturing (CMC) · Supplement 31AP
2002-03-20Manufacturing (CMC) · Supplement 27AP
2002-03-20Manufacturing (CMC) · Supplement 28AP
2002-03-14Manufacturing (CMC) · Supplement 29AP
2001-09-10Manufacturing (CMC) · Supplement 25AP
2001-09-10Manufacturing (CMC) · Supplement 23AP
2001-09-10Manufacturing (CMC) · Supplement 24AP
2001-07-27Manufacturing (CMC) · Supplement 22AP
2001-07-13Labeling · Supplement 26AP
2001-05-15Manufacturing (CMC) · Supplement 20AP
2001-03-23Labeling · Supplement 21AP
2001-01-04Manufacturing (CMC) · Supplement 19AP
2000-07-07Manufacturing (CMC) · Supplement 18AP
2000-06-12Manufacturing (CMC) · Supplement 17AP
1999-04-06Labeling · Supplement 16AP
1996-08-28Manufacturing (CMC) · Supplement 15AP
1996-07-03Manufacturing (CMC) · Supplement 12AP
1996-06-05Manufacturing (CMC) · Supplement 13AP
1996-06-05Manufacturing (CMC) · Supplement 11AP
1996-06-05Manufacturing (CMC) · Supplement 14AP
1996-04-01Manufacturing (CMC) · Supplement 10AP
1996-02-28Manufacturing (CMC) · Supplement 9AP
1995-09-11Manufacturing (CMC) · Supplement 3AP
1995-09-11Labeling · Supplement 1AP
1995-09-11Manufacturing (CMC) · Supplement 2AP
1993-08-26Manufacturing (CMC) · Supplement 6AP
1993-07-12Labeling · Supplement 7AP
1993-05-13Manufacturing (CMC) · Supplement 4AP
1993-05-12Manufacturing (CMC) · Supplement 5AP
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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