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FDA ANDA · ANDA205187
AMOXICILLIN AND CLAVULANATE POTASSIUM
Sponsor: MICRO LABS LTD INDIA
APPLICATION
ANDA205187
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-21
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 200MG/5ML, CLAVULANATE POTASSIUM EQ 28.5MG BASE/5ML · FOR SUSPENSION · ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 400MG/5ML, CLAVULANATE POTASSIUM EQ 57MG BASE/5ML · FOR SUSPENSION · ORAL
Approval history
2024-05-01Labeling · Supplement 4 · standardAP
2024-04-16Labeling · Supplement 3 · standardAP
2021-05-21UNKNOWN · 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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