APPLICATION
ANDA065004
TYPE
ANDA
ORIGINAL APPROVAL
1999-10-29
LATEST ACTION
2010-10-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYCLOSPORINEPrescription
CYCLOSPORINE 50MG/ML · INJECTABLE · INJECTION
Approval history
2010-10-18Labeling · Supplement 8AP
2010-09-23Labeling · Supplement 7AP
2002-04-30Labeling · Supplement 1AP
2001-04-03Manufacturing (CMC) · 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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