Last Updated: May 3, 2026

Details for New Drug Application (NDA): 040282

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NDA 040282 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 040282

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

Medical Subject Heading (MeSH) Categories for 040282

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Dec 23, 1999	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Dec 23, 1999	TE:	AB	RLD:	No

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