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FDA ANDA · ANDA065420

AMOXICILLIN AND CLAVULANATE POTASSIUM

Sponsor: CIPLA

APPLICATION
ANDA065420
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-02
LATEST ACTION
2016-10-10
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

AMOXICILLIN AND CLAVULANATE POTASSIUMPrescription
AMOXICILLIN 600MG/5ML, CLAVULANATE POTASSIUM EQ 42.9MG BASE/5ML · FOR SUSPENSION · ORAL

Approval history

2016-10-10Labeling · Supplement 2 · standardAP
2013-12-02OriginalAP
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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