APPLICATION
ANDA065025
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-03
LATEST ACTION
2025-04-04
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CYCLOSPORINEDiscontinued
CYCLOSPORINE 100MG/ML · SOLUTION · ORAL
Approval history
2025-04-04Labeling · Supplement 26 · standardAP
2025-04-04Labeling · Supplement 27 · standardAP
2015-10-06Labeling · Supplement 20 · standardAP
2015-10-06Labeling · Supplement 23 · standardAP
2015-10-06Labeling · Supplement 21 · standardAP
2013-02-06Labeling · Supplement 19 · standardAP
2010-04-27Labeling · Supplement 16AP
2009-12-09Labeling · Supplement 14AP
2009-12-09Labeling · Supplement 13AP
2007-07-13Labeling · Supplement 12AP
2007-02-26Labeling · Supplement 11AP
2007-02-07Labeling · Supplement 10AP
2005-10-05Labeling · Supplement 6AP
2005-09-01Labeling · Supplement 7AP
2004-04-26Labeling · Supplement 5AP
2001-12-14Labeling · Supplement 4AP
2001-08-15Bioequivalence · Supplement 3AP
2000-09-05Manufacturing (CMC) · Supplement 1AP
2000-08-09Labeling · Supplement 2AP
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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