APPLICATION
ANDA065418
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-18
LATEST ACTION
2020-08-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CEFDINIRPrescription
CEFDINIR 300MG · CAPSULE · ORAL
Approval history
2020-08-21Labeling · Supplement 9 · standardAP
2010-05-27Labeling · Supplement 6AP
2009-07-20Labeling · Supplement 4AP
2008-09-18Labeling · Supplement 2AP
2008-02-07Labeling · Supplement 1AP
2007-07-18OriginalAP
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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