Alprostadil

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Oct 16, 1981	Prostin Vr PediatricNDA 18484 · New molecular entity	Pfizer	19	Marketed
Jul 6, 1995	CaverjectNDA 20379 · New dosage form	Pfizer	26	Marketed
Nov 19, 1996	MuseNDA 20700 · New dosage form	Viatris	12	Discontinued
Jun 12, 1997	EdexNDA 20649 · New dosage form	Endo Operations	18	Marketed
Oct 31, 1997	CaverjectNDA 20755 · New formulation or manufacturer	Pfizer	2	Discontinued
Jan 20, 1998	AlprostadilANDA 74815	Hikma	5	Marketed
Apr 30, 1999	AlprostadilANDA 75196	Meitheal	2	Marketed
Jun 11, 2002	Caverject ImpulseNDA 21212 · New dosage form	Pfizer	10	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