Last Updated: May 3, 2026

Details for New Drug Application (NDA): 215209

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NDA 215209 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 215209

Tradename:	DIGOXIN
Applicant:	Amici Pharma
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 215209

Medical Subject Heading (MeSH) Categories for 215209

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 215209

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	ELIXIR;ORAL	215209	ANDA	Amici Pharma, Inc	69292-605	69292-605-60	1 BOTTLE in 1 CARTON (69292-605-60) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ELIXIR;ORAL			Strength	0.05MG/ML
Approval Date:	Mar 11, 2022	TE:	AA	RLD:	No

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