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FDA ANDA · ANDA200563

CIPROFLOXACIN

Sponsor: CHARTWELL

APPLICATION
ANDA200563
TYPE
ANDA
ORIGINAL APPROVAL
2014-03-05
LATEST ACTION
2015-10-14
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

CIPROFLOXACINPrescription
CIPROFLOXACIN 500MG/5ML · FOR SUSPENSION · ORAL
CIPROFLOXACINPrescription
CIPROFLOXACIN 250MG/5ML · FOR SUSPENSION · ORAL

Approval history

2015-10-14Labeling · Supplement 2 · standardAP
2015-02-06Manufacturing (CMC) · Supplement 1AP
2014-03-05Not Applicable · OriginalLetterAP
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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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