APPLICATION
ANDA065282
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-20
LATEST ACTION
2008-07-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CEFADROXILPrescription
CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE · CAPSULE · ORAL
Approval history
2008-07-17Labeling · Supplement 1AP
2006-01-20OriginalAP
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.