Cefadroxil/Cefadroxil Hemihydrate

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Feb 17, 1978	DuricefNDA 50512 · New molecular entity	Warner Chilcott	36	Discontinued
Jul 30, 1980	CefadroxilANDA 62291	Sandoz	9	Discontinued
Aug 6, 1980	DuricefNDA 50528 · New dosage form	Warner Chilcott	11	Discontinued
Sep 12, 1980	DuricefNDA 50527 · New dosage form	Warner Chilcott	18	Discontinued
Mar 3, 1987	CefadroxilANDA 62766	Ivax Sub Teva Pharms	12	Discontinued
Apr 8, 1987	CefadroxilANDA 62774	Teva Pharms	11	Marketed
Jan 5, 1989	CefadroxilANDA 63017	Purepac Pharm	3	Discontinued
Feb 10, 1989	CefadroxilANDA 62695	Teva	7	Discontinued
Mar 1, 1989	CefadroxilANDA 62698	Ani Pharms	7	Discontinued
Apr 23, 1999	CefadroxilANDA 65018	Ranbaxy	2	Discontinued
Jun 22, 1999	CefadroxilANDA 65015	Ranbaxy Labs Ltd	4	Discontinued
Mar 26, 2003	CefadroxilANDA 65115	Sun Pharm Inds Ltd	3	Discontinued
Jan 20, 2006	CefadroxilANDA 65278	Ani Pharms	0	Discontinued
Jan 20, 2006	CefadroxilANDA 65282	Teva Pharms	1	Marketed
Feb 7, 2006	CefadroxilANDA 65311	Hikma	1	Discontinued
Mar 30, 2006	CefadroxilANDA 65260	Hikma	2	Discontinued
Sep 18, 2006	CefadroxilANDA 65301	Chartwell Rx	1	Discontinued
Sep 18, 2006	CefadroxilANDA 65309	Chartwell Rx	2	Discontinued
Oct 16, 2006	CefadroxilANDA 65307	Chartwell Rx	3	Discontinued
Jan 25, 2007	CefadroxilANDA 65352	Aurobindo Pharma	2	Marketed
May 29, 2007	CefadroxilANDA 65392	Lupin	1	Marketed
Feb 21, 2008	CefadroxilANDA 65396	Lupin	1	Marketed
Nov 28, 2012	CefadroxilANDA 91036	Hikma Pharms	2	Discontinued
Apr 25, 2013	CefadroxilANDA 65349	Aurobindo	1	Marketed
Jul 28, 2017	CefadroxilANDA 205072	Cspc Ouyi	0	Discontinued
—	CefadroxilANDA 62334	Apothecon	0	Discontinued
—	UltracefANDA 62376	Bristol	0	Discontinued
—	UltracefANDA 62378	Bristol	0	Discontinued
—	UltracefANDA 62390	Apothecon	0	Discontinued
—	UltracefANDA 62408	Bristol	0	Discontinued

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