APPLICATION
ANDA065040
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-09
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CYCLOSPORINEPrescription
CYCLOSPORINE 25MG · CAPSULE · ORAL
CYCLOSPORINEPrescription
CYCLOSPORINE 100MG · CAPSULE · ORAL
Approval history
2025-08-01Labeling · Supplement 16 · standardAP
2025-08-01Labeling · Supplement 20 · standardAP
2014-02-26Labeling · Supplement 8AP
2014-02-26Labeling · Supplement 9 · standardAP
2006-06-27Labeling · Supplement 5AP
2006-05-08Labeling · Supplement 4AP
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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