Levorphanol Tartrate

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Jan 8, 1953	Levo-DromoranNDA 8719 · New dosage form	Valeant Pharm Intl	21	Discontinued
Jan 8, 1953	Levo-DromoranNDA 8720 · New dosage form	Valeant Pharm Intl	8	Discontinued
Mar 31, 2000	Levorphanol TartrateANDA 74278	Hikma	16	Marketed
Dec 13, 2018	Levorphanol TartrateANDA 211484	Acertis Pharms	8	Marketed
Dec 13, 2019	Levorphanol TartrateANDA 212024	Specgx LLC	5	Marketed
Jul 1, 2020	Levorphanol TartrateANDA 213479	Novitium Pharma	4	Marketed
Jun 17, 2021	Levorphanol TartrateANDA 213906	Sun Pharm Inds Inc	4	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