APPLICATION
ANDA077027
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-24
LATEST ACTION
2020-12-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CILOSTAZOLPrescription
CILOSTAZOL 100MG · TABLET · ORAL
CILOSTAZOLPrescription
CILOSTAZOL 50MG · TABLET · ORAL
Approval history
2020-12-18Labeling · Supplement 19 · standardAP
2016-04-04Labeling · Supplement 16 · standardAP
2016-04-04Labeling · Supplement 17 · standardAP
2014-12-31Labeling · Supplement 10AP
2014-11-06Manufacturing (CMC) · Supplement 8AP
2014-09-23Labeling · Supplement 7AP
2012-03-09Labeling · Supplement 13AP
2008-06-27Labeling · Supplement 5AP
2006-12-07Labeling · Supplement 3AP
2006-05-08Labeling · Supplement 2AP
2004-11-24OriginalAP
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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