Rufinamide

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Nov 14, 2008	BanzelNDA 21911 · New molecular entity	Eisai Inc	9	Marketed
Mar 3, 2011	BanzelNDA 201367 · New dosage form	Eisai Inc	7	Marketed
May 16, 2016	RufinamideANDA 204988	Hikma	1	Marketed
May 16, 2016	RufinamideANDA 205075	Glenmark Pharms Ltd	1	Marketed
May 16, 2016	RufinamideANDA 205095	Sciegen Pharms	1	Marketed
Apr 23, 2019	RufinamideANDA 207363	Hikma	1	Marketed
Apr 23, 2019	RufinamideANDA 211388	Bionpharma	1	Marketed
Dec 18, 2020	RufinamideANDA 213457	Lupin	1	Marketed
Feb 23, 2021	RufinamideANDA 213410	Alkem Labs Ltd	1	Marketed
May 11, 2021	RufinamideANDA 204993	Hetero Labs Ltd Iii	0	Marketed
Aug 17, 2022	RufinamideANDA 204964	Lupin	0	Marketed
Oct 26, 2022	RufinamideANDA 216549	Aurobindo Pharma	0	Marketed
Nov 7, 2022	RufinamideANDA 214009	Chartwell Rx	0	Marketed
May 15, 2023	RufinamideANDA 216688	Micro Labs	0	Marketed
Jun 16, 2023	RufinamideANDA 217230	Aurobindo Pharma	0	Marketed
Dec 5, 2023	RufinamideANDA 216841	Hetero Labs Ltd Iii	0	Marketed
Apr 15, 2025	RufinamideANDA 214817	Msn	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