Digoxin

Sold as Lanoxin, Lanoxin Pediatric, Lanoxicaps, Digoxin. Every FDA application for this active ingredient: 4 branded and 16 generic.

As of Nov 13, 2026, FDA lists 20 applications for Digoxin (sold as Lanoxin, Lanoxin Pediatric, Lanoxicaps and others), first approved Nov 16, 1954, with 1 new use approved and 0 published complete response letters.

First approved: Nov 16, 1954
Applications: 20
New uses approved: 1
Complete response letters: 0
Medicare spending, 2024: $37.8M

Medicare Spending

CMS Part D and Part B, 2024, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2024	Change	Beneficiaries
Digoxin	Part D	$36.9M	-26%	370,872
Lanoxin	Part D	$967K	-20%	214
Digoxin	Part B	$0K	+28%	22

Applications

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

Approved	Application	Sponsor	Supplements	Marketing
Nov 16, 1954	Lanoxin, Lanoxin PediatricNDA 9330 · New molecular entity	Azurity	17	Discontinued
Oct 24, 1975	DigoxinANDA 83391	Hikma	13	Marketed
Jul 12, 1976	DigoxinANDA 84386	Wyeth Ayerst	5	Discontinued
Jul 26, 1982	LanoxicapsNDA 18118 · New dosage form	Glaxosmithkline LLC	17	Discontinued
Apr 25, 1996	Digoxin PediatricANDA 40092	Hospira	3	Discontinued
May 16, 1996	DigoxinANDA 40093	Hospira	5	Discontinued
Sep 30, 1997	LanoxinNDA 20405 · TYPE 7	Advanz Pharma	14	Marketed
Aug 28, 1998	DigoxinANDA 40206	Hospira	1	Discontinued
Dec 23, 1999	DigoxinANDA 40282	Rising	11	Marketed
Jul 26, 2002	DigoxinANDA 76268	Stevens J	1	Marketed
Jan 31, 2003	DigoxinANDA 76363	Sun Pharm Inds Inc	8	Discontinued
Aug 21, 2003	DigoxinANDA 40481	Sandoz	7	Marketed
Aug 26, 2004	DigoxinNDA 21648 · TYPE 7	Hikma	9	Marketed
Oct 30, 2007	DigoxinANDA 77002	Hikma	8	Marketed
Jul 20, 2009	DigoxinANDA 78556	Impax Labs	8	Discontinued
Oct 4, 2019	DigoxinANDA 213000	Vistapharm LLC	0	Marketed
Nov 22, 2021	DigoxinANDA 215307	Novitium Pharma	1	Marketed
Feb 8, 2022	DigoxinANDA 214982	Aurobindo Pharma Ltd	1	Marketed
Mar 11, 2022	DigoxinANDA 215209	Pangea	0	Marketed
—	DigoxinANDA 83217	Abraxis 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. Drugs@FDA