Last Updated: May 3, 2026

Details for New Drug Application (NDA): 021648

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NDA 021648 describes DIGOXIN, which is a drug marketed by Amici Pharma, Hikma, Vistapharm Llc, Abraxis Pharm, Hospira, Sandoz, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Novitium Pharma, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-six suppliers. Additional details are available on the DIGOXIN profile page.

The generic ingredient in DIGOXIN is digoxin. There are ten drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 021648

Tradename:	DIGOXIN
Applicant:	Hikma
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 021648

Medical Subject Heading (MeSH) Categories for 021648

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 021648

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	ELIXIR;ORAL	021648	NDA	Hikma Pharmaceuticals USA Inc.	0054-0057	0054-0057-46	60 mL in 1 BOTTLE (0054-0057-46)
DIGOXIN	digoxin	ELIXIR;ORAL	021648	NDA	Atlantic Biologicals Corps	17856-0057	17856-0057-1	2.5 mL in 1 CUP, UNIT-DOSE (17856-0057-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ELIXIR;ORAL			Strength	0.05MG/ML
Approval Date:	Aug 26, 2004	TE:	AA	RLD:	Yes

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