APPLICATION
ANDA075405
TYPE
ANDA
ORIGINAL APPROVAL
2000-02-28
LATEST ACTION
2013-01-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CLADRIBINEPrescription
CLADRIBINE 1MG/ML · INJECTABLE · INJECTION
Approval history
2013-01-08Labeling · Supplement 9 · standardAP
2007-02-07Labeling · Supplement 6AP
2001-04-03Manufacturing (CMC) · Supplement 3AP
2000-11-03Labeling · Supplement 2AP
2000-11-03Manufacturing (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.
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.