APPLICATION
ANDA065017
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-13
LATEST ACTION
2016-01-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
CYCLOSPORINEPrescription
CYCLOSPORINE 25MG · CAPSULE · ORAL
CYCLOSPORINEPrescription
CYCLOSPORINE 100MG · CAPSULE · ORAL
Approval history
2016-01-04Labeling · Supplement 22 · standardAP
2016-01-04Manufacturing (CMC) · Supplement 21 · unknownAP
2013-07-08Labeling · Supplement 20 · standardAP
2012-12-11Labeling · Supplement 15 · standardAP
2012-01-27Labeling · Supplement 14AP
2007-02-06Labeling · Supplement 11AP
2003-04-19Labeling · Supplement 8AP
2002-04-19Manufacturing (CMC) · Supplement 7AP
2001-12-06Labeling · Supplement 4AP
2001-12-06Manufacturing (CMC) · Supplement 5AP
2001-09-07Manufacturing (CMC) · Supplement 6AP
2000-05-11Manufacturing (CMC) · Supplement 2AP
2000-05-11Manufacturing (CMC) · Supplement 3AP
2000-05-11Manufacturing (CMC) · 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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