Last Updated: September 28, 2026

Details for New Drug Application (NDA): 076268

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NDA 076268 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-seven suppliers. Additional details are available on the DIGOXIN profile page.

The generic ingredient in DIGOXIN is digoxin. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 076268

Tradename:	DIGOXIN
Applicant:	Stevens J
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 076268

Medical Subject Heading (MeSH) Categories for 076268

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 076268

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	TABLET;ORAL	076268	ANDA	Amneal Pharmaceuticals NY LLC	69238-1991	69238-1991-1	100 TABLET in 1 BOTTLE (69238-1991-1)
DIGOXIN	digoxin	TABLET;ORAL	076268	ANDA	Amneal Pharmaceuticals NY LLC	69238-1991	69238-1991-7	1000 TABLET in 1 BOTTLE (69238-1991-7)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Jul 26, 2002	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Jul 26, 2002	TE:	AB	RLD:	No

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