APPLICATION
ANDA065337
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-06
LATEST ACTION
2020-05-12
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
CEFDINIRPrescription
CEFDINIR 250MG/5ML · FOR SUSPENSION · ORAL
CEFDINIRPrescription
CEFDINIR 125MG/5ML · FOR SUSPENSION · ORAL
Approval history
2020-05-12Labeling · Supplement 12 · standardAP
2020-05-12Labeling · Supplement 15 · standardAP
2009-05-14Labeling · Supplement 5AP
2008-12-17Labeling · Supplement 2AP
2007-04-06OriginalAP
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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