APPLICATION
ANDA065264
TYPE
ANDA
ORIGINAL APPROVAL
2006-05-19
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 21 · standardAP
2010-02-01Manufacturing (CMC) · Supplement 9AP
2008-06-11Labeling · Supplement 4AP
2007-12-20Labeling · Supplement 3AP
2007-09-07Labeling · Supplement 2AP
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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