Fludarabine Phosphate

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Apr 18, 1991	FludaraNDA 20038 · New molecular entity	Genzyme Corp	22	Discontinued
Aug 28, 2003	Fludarabine PhosphateANDA 76349	Hikma	2	Marketed
Apr 28, 2004	Fludarabine PhosphateANDA 76661	Sagent Pharms Inc	1	Marketed
Apr 6, 2007	Fludarabine PhosphateANDA 77790	Hospira	2	Discontinued
Sep 21, 2007	Fludarabine PhosphateNDA 22137 · New formulation or manufacturer	Caplin One Labs	9	Discontinued
Oct 15, 2007	Fludarabine PhosphateANDA 78393	Fresenius Kabi USA	0	Marketed
Oct 15, 2007	Fludarabine PhosphateANDA 78544	Fresenius Kabi USA	0	Marketed
Dec 18, 2008	OfortaNDA 22273 · New formulation or manufacturer	Sanofi Aventis US	1	Discontinued
Feb 11, 2009	Fludarabine PhosphateANDA 78610	Actavis Totowa	2	Marketed
Sep 27, 2010	Fludarabine PhosphateANDA 90724	Areva Pharms	4	Marketed
Dec 21, 2011	Fludarabine PhosphateANDA 200647	Pharmazone	0	Discontinued
Oct 16, 2012	Fludarabine PhosphateANDA 200648	Rising	0	Discontinued
Feb 28, 2017	Fludarabine PhosphateANDA 203738	Actavis LLC	1	Discontinued
Jul 23, 2026	Fludarabine PhosphateANDA 220196	Hisun Pharm Hangzhou	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA