Pentamidine Isethionate

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Oct 16, 1984	PentamNDA 19264 · New molecular entity	Fresenius Kabi USA	19	Marketed
Jun 15, 1989	NebupentNDA 19887 · New dosage form	Fresenius Kabi USA	8	Marketed
Jun 30, 1992	Pentamidine IsethionateANDA 73479	Hospira	8	Discontinued
Aug 17, 1995	Pentamidine IsethionateANDA 74303	Watson Labs	12	Discontinued
Dec 18, 1995	Pentamidine IsethionateANDA 73617	Baxter Hlthcare	2	Discontinued
Sep 28, 2017	Pentamidine IsethionateANDA 206666	Pai Holdings	0	Marketed
Apr 24, 2019	Pentamidine IsethionateANDA 206667	Pai Holdings	0	Marketed
Jan 7, 2021	Pentamidine IsethionateANDA 213806	Avet Lifesciences	0	Marketed
Mar 17, 2022	Pentamidine IsethionateANDA 206982	Pharmobedient	0	Discontinued
Jan 20, 2023	Pentamidine IsethionateANDA 206983	X-Gen Pharms Inc	0	Marketed
—	PentacarinatANDA 73447	Armour Pharm	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