APPLICATION
ANDA065259
TYPE
ANDA
ORIGINAL APPROVAL
2006-05-31
LATEST ACTION
2010-02-01
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CEFDINIRPrescription
CEFDINIR 125MG/5ML · FOR SUSPENSION · ORAL
CEFDINIRPrescription
CEFDINIR 250MG/5ML · FOR SUSPENSION · ORAL
Approval history
2010-02-01Manufacturing (CMC) · Supplement 13AP
2008-06-11Labeling · Supplement 6AP
2007-12-13Labeling · Supplement 5AP
2007-09-11Labeling · Supplement 4AP
2007-05-07Manufacturing (CMC) · Supplement 1AP
2007-05-07Labeling · 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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