APPLICATION
ANDA065021
TYPE
ANDA
ORIGINAL APPROVAL
1999-12-23
LATEST ACTION
2008-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
AMOXICILLINDiscontinued
AMOXICILLIN 250MG · TABLET, CHEWABLE · ORAL
AMOXICILLINDiscontinued
AMOXICILLIN 125MG · TABLET, CHEWABLE · ORAL
Approval history
2008-06-30Labeling · Supplement 16AP
2006-07-31Labeling · Supplement 14AP
2006-05-04Labeling · Supplement 13AP
2006-04-07Labeling · Supplement 11AP
2005-11-29Labeling · Supplement 10AP
2004-04-23Labeling · Supplement 5AP
2003-09-29Labeling · Supplement 4AP
2000-12-22Labeling · Supplement 2AP
2000-06-29Manufacturing (CMC) · Supplement 1AP
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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