APPLICATION
ANDA062058
TYPE
ANDA
ORIGINAL APPROVAL
1978-08-03
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 15 · standardAP
2011-02-07Labeling · Supplement 8AP
1997-07-15Labeling · Supplement 1AP
1978-08-03OriginalAP
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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