APPLICATION
ANDA065271
TYPE
ANDA
ORIGINAL APPROVAL
2005-11-09
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMOXICILLINPrescription
AMOXICILLIN 500MG · CAPSULE · ORAL
AMOXICILLINPrescription
AMOXICILLIN 250MG · CAPSULE · ORAL
Approval history
2024-05-01Labeling · Supplement 25 · standardAP
2024-04-04Labeling · Supplement 19 · standardAP
2024-04-04Labeling · Supplement 23 · standardAP
2024-04-04Labeling · Supplement 15 · standardAP
2024-04-04Labeling · Supplement 16 · standardAP
2013-02-21Labeling · Supplement 9AP
2009-03-31Labeling · Supplement 5AP
2008-10-28Labeling · Supplement 4AP
2005-11-09OriginalAP
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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