Cefpodoxime Proxetil

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Aug 7, 1992	VantinNDA 50674 · New molecular entity	Pfizer	13	Discontinued
Aug 7, 1992	VantinNDA 50675 · New dosage form	Pfizer	18	Discontinued
Aug 7, 1992	BananNDA 50687 · New dosage form	Sankyo	12	Discontinued
Aug 7, 1992	BananNDA 50688 · New dosage form	Sankyo	13	Discontinued
May 31, 2002	Cefpodoxime ProxetilANDA 65082	Sun Pharm Inds Ltd	2	Discontinued
Aug 20, 2003	Cefpodoxime ProxetilANDA 65083	Sun Pharm Inds Ltd	2	Discontinued
Jun 8, 2007	Cefpodoxime ProxetilANDA 65409	Aurobindo Pharma Ltd	2	Marketed
Jun 11, 2007	Cefpodoxime ProxetilANDA 65370	Aurobindo Pharma	3	Marketed
Nov 14, 2007	Cefpodoxime ProxetilANDA 65388	Anda Repository	1	Marketed
May 28, 2008	Cefpodoxime ProxetilANDA 65462	Sandoz	1	Marketed
Jan 14, 2009	Cefpodoxime ProxetilANDA 90031	Chartwell Rx	1	Discontinued
May 18, 2022	Cefpodoxime ProxetilANDA 210568	Alkem Labs Ltd	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