Glimepiride

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Nov 30, 1995	AmarylNDA 20496 · New molecular entity	Sanofi Aventis US	23	Discontinued
Oct 6, 2005	GlimepirideANDA 76802	Pharmazone	11	Discontinued
Oct 6, 2005	GlimepirideANDA 77091	Dr Reddys Labs Ltd	9	Marketed
Oct 6, 2005	GlimepirideANDA 77274	Epic Pharma LLC	7	Discontinued
Oct 6, 2005	GlimepirideANDA 77295	Chartwell Molecular	6	Marketed
Oct 6, 2005	GlimepirideANDA 77366	Ranbaxy	0	Discontinued
Nov 28, 2005	GlimepirideANDA 77624	Quagen	5	Discontinued
Dec 23, 2005	GlimepirideANDA 77370	Prinston	5	Marketed
Feb 3, 2006	GlimepirideANDA 77280	Watson Labs	2	Discontinued
Feb 10, 2006	GlimepirideANDA 77486	Mylan	0	Discontinued
Aug 23, 2007	GlimepirideANDA 78181	Accord Hlthcare	7	Marketed
Sep 22, 2009	GlimepirideANDA 77911	Carlsbad	3	Marketed
Apr 26, 2010	GlimepirideANDA 76995	Actavis Labs Fl Inc	0	Discontinued
Jun 29, 2012	GlimepirideANDA 91220	Micro Labs	5	Marketed
Jun 29, 2012	GlimepirideANDA 202759	Aurobindo Pharma Ltd	3	Marketed
Apr 17, 2013	GlimepirideANDA 202112	Regcon Holdings	2	Marketed
Aug 1, 2013	GlimepirideANDA 78952	Hikma Pharms	0	Discontinued
—	GlimepirideANDA 76875	Ranbaxy Labs Ltd	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