APPLICATION
ANDA065151
TYPE
ANDA
ORIGINAL APPROVAL
2003-10-07
LATEST ACTION
2015-06-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CYCLOSPORINEDiscontinued
CYCLOSPORINE 50MG/ML · INJECTABLE · INJECTION
Approval history
2015-06-30Labeling · Supplement 13 · standardAP
2015-06-30Labeling · Supplement 10AP
2012-01-31Labeling · Supplement 9AP
2006-10-10Labeling · Supplement 4AP
2005-06-24Labeling · Supplement 3AP
2003-10-07OriginalAP
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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