APPLICATION
ANDA065332
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-04
LATEST ACTION
2023-06-06
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
2023-06-06Labeling · Supplement 17 · standardAP
2020-03-09Labeling · Supplement 16 · standardAP
2020-03-09Labeling · Supplement 14 · standardAP
2009-08-27Labeling · Supplement 9AP
2008-10-17Labeling · Supplement 8AP
2008-06-12Labeling · Supplement 6AP
2008-03-07Labeling · Supplement 5AP
2007-05-04OriginalAP
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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