Naltrexone Hydrochloride

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Nov 20, 1984	ReviaNDA 18932 · New molecular entity	Teva Womens	12	Discontinued
May 8, 1998	Naltrexone HydrochlorideANDA 74918	Barr	12	Marketed
May 26, 1999	Naltrexone HydrochlorideANDA 75274	Elite Labs	1	Marketed
Mar 8, 2000	Naltrexone HydrochlorideANDA 75434	Novitium Pharma	2	Marketed
Mar 22, 2002	Naltrexone HydrochlorideANDA 76264	Specgx LLC	0	Marketed
Aug 17, 2011	Naltrexone HydrochlorideANDA 91205	Accord Hlthcare	1	Marketed
Feb 24, 2012	Naltrexone HydrochlorideANDA 90356	Sun Pharm	1	Marketed
Jul 21, 2017	Naltrexone HydrochlorideANDA 207905	Chartwell	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