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FDA ANDA · ANDA205707
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: MICRO LABS LTD INDIA
APPLICATION
ANDA205707
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-30
LATEST ACTION
2024-12-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 500MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 250MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL
Approval history
2024-12-11Labeling · Supplement 13 · standardAP
2024-05-01Labeling · Supplement 12 · standardAP
2024-04-04Labeling · Supplement 9 · standardAP
2024-04-04Labeling · Supplement 5 · standardAP
2024-04-04Labeling · Supplement 6 · standardAP
2017-10-23Labeling · Supplement 2 · standardAP
2016-12-30UNKNOWN · Original · standardAP
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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