APPLICATION
ANDA065236
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-08
LATEST ACTION
2025-07-25
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
CEFPROZILDiscontinued
CEFPROZIL 125MG/5ML · FOR SUSPENSION · ORAL
CEFPROZILDiscontinued
CEFPROZIL 250MG/5ML · FOR SUSPENSION · ORAL
Approval history
2025-07-25Labeling · Supplement 7 · standardAP
2018-04-09Labeling · Supplement 6 · standardAP
2009-03-04Labeling · Supplement 5AP
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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