APPLICATION
ANDA040032
TYPE
ANDA
ORIGINAL APPROVAL
1999-08-17
LATEST ACTION
2007-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CYCLOPHOSPHAMIDEDiscontinued
CYCLOPHOSPHAMIDE 50MG · TABLET · ORAL
CYCLOPHOSPHAMIDEDiscontinued
CYCLOPHOSPHAMIDE 25MG · TABLET · ORAL
Approval history
2007-11-21Labeling · Supplement 12AP
2007-01-10Labeling · Supplement 9AP
2002-07-17Manufacturing (CMC) · Supplement 4AP
2002-07-17Labeling · Supplement 5AP
2002-07-17Manufacturing (CMC) · Supplement 3AP
2000-02-16Labeling · 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.