APPLICATION
ANDA065434
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-07
LATEST ACTION
2020-02-11
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CEFDINIRPrescription
CEFDINIR 300MG · CAPSULE · ORAL
Approval history
2020-02-11Labeling · Supplement 5 · standardAP
2020-02-11Labeling · Supplement 6 · standardAP
2009-04-28Labeling · Supplement 3AP
2008-01-07OriginalAP
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.