APPLICATION
ANDA090227
TYPE
ANDA
ORIGINAL APPROVAL
2010-04-21
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 1GM, CLAVULANATE POTASSIUM EQ 62.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-05-01Labeling · Supplement 19 · standardAP
2024-04-30Labeling · Supplement 18 · standardAP
2016-01-05Labeling · Supplement 8 · standardAP
2015-01-16Labeling · Supplement 7 · standardAP
2012-09-04Labeling · Supplement 4AP
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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