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FDA ANDA · ANDA065284

CEFPROZIL

Sponsor: ORCHID HLTHCARE

APPLICATION
ANDA065284
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-30
LATEST ACTION
2018-04-09
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued

Products

CEFPROZILDiscontinued
CEFPROZIL 250MG/5ML · FOR SUSPENSION · ORAL
CEFPROZILDiscontinued
CEFPROZIL 125MG/5ML · FOR SUSPENSION · ORAL

Approval history

2018-04-09Labeling · Supplement 12 · standardAP
2008-06-03Labeling · Supplement 4AP
2006-05-30Labeling · Supplement 1AP
2005-12-30OriginalAP
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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