APPLICATION
ANDA065003
TYPE
ANDA
ORIGINAL APPROVAL
2000-05-12
LATEST ACTION
2025-04-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued
Products
GENGRAFPrescription
CYCLOSPORINE 25MG · CAPSULE · ORAL
GENGRAFDiscontinued
CYCLOSPORINE 50MG · CAPSULE · ORAL
GENGRAFPrescription
CYCLOSPORINE 100MG · CAPSULE · ORAL
Approval history
2025-04-04Labeling · Supplement 20 · standardAP
2015-06-30Labeling · Supplement 17 · standardAP
2015-06-30Labeling · Supplement 18 · standardAP
2015-06-30Labeling · Supplement 10AP
2013-02-06Labeling · Supplement 16 · standardAP
2010-05-05Labeling · Supplement 13AP
2009-12-09Labeling · Supplement 11AP
2007-07-13Labeling · Supplement 9AP
2007-02-26Labeling · Supplement 8AP
2007-02-07Labeling · Supplement 7AP
2005-09-01Labeling · Supplement 6AP
2005-09-01Labeling · Supplement 5AP
2004-05-14Labeling · Supplement 2AP
2001-12-14Labeling · 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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