APPLICATION
ANDA065044
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-20
LATEST ACTION
2015-01-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CYCLOSPORINEPrescription
CYCLOSPORINE 100MG · CAPSULE · ORAL
CYCLOSPORINEPrescription
CYCLOSPORINE 25MG · CAPSULE · ORAL
Approval history
2015-01-20Labeling · Supplement 17 · standardAP
2007-11-16Labeling · Supplement 10AP
2007-02-05Labeling · Supplement 8AP
2004-12-02Labeling · Supplement 4AP
2004-05-14Labeling · Supplement 3AP
2002-05-03Labeling · Supplement 2AP
2002-05-03Labeling · Supplement 1AP
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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