APPLICATION
ANDA065167
TYPE
ANDA
ORIGINAL APPROVAL
2005-01-05
LATEST ACTION
2020-07-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CYCLOSPORINEDiscontinued
CYCLOSPORINE 100MG/ML · SOLUTION · ORAL
Approval history
2020-07-27Labeling · Supplement 15 · standardAP
2010-11-18Labeling · Supplement 11AP
2009-12-09Labeling · Supplement 9AP
2008-07-17Labeling · Supplement 6AP
2006-06-20Labeling · Supplement 2AP
2005-11-29Labeling · Supplement 1AP
2005-01-05OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.