APPLICATION
ANDA065261
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-19
LATEST ACTION
2025-08-22
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CEFPROZILPrescription
CEFPROZIL 250MG/5ML · FOR SUSPENSION · ORAL
CEFPROZILPrescription
CEFPROZIL 125MG/5ML · FOR SUSPENSION · ORAL
Approval history
2025-08-22Manufacturing (CMC) · Supplement 21 · unknownAP
2018-04-09Labeling · Supplement 15 · standardAP
2008-01-07Labeling · Supplement 6AP
2007-07-27Labeling · Supplement 2AP
2005-12-19OriginalAP
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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