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FDA ANDA · ANDA203824

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: HIKMA PHARMS

APPLICATION
ANDA203824
TYPE
ANDA
ORIGINAL APPROVAL
2016-08-23
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 875MG, CLAVULANATE POTASSIUM EQ 125MG BASE · TABLET · ORAL

Approval history

2023-06-07Labeling · Supplement 13 · standardAP
2016-08-23Not Applicable · Supplement 1 · unknownAP
2016-08-23UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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