APPLICATION
ANDA065276
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-08
LATEST ACTION
2018-04-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CEFPROZILPrescription
CEFPROZIL 500MG · TABLET · ORAL
CEFPROZILPrescription
CEFPROZIL 250MG · TABLET · ORAL
Approval history
2018-04-09Labeling · Supplement 9 · standardAP
2008-01-16Labeling · Supplement 3AP
2005-12-08OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.