Last Updated: September 24, 2026

Details for New Drug Application (NDA): 078556

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NDA 078556 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 078556

Tradename:	DIGOXIN
Applicant:	Impax Labs
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 078556

Medical Subject Heading (MeSH) Categories for 078556

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 078556

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	TABLET;ORAL	078556	ANDA	Amneal Pharmaceuticals of New York LLC	0115-9811	0115-9811-01	100 TABLET in 1 BOTTLE (0115-9811-01)
DIGOXIN	digoxin	TABLET;ORAL	078556	ANDA	Amneal Pharmaceuticals of New York LLC	0115-9811	0115-9811-02	500 TABLET in 1 BOTTLE (0115-9811-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Jul 20, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Jul 20, 2009	TE:		RLD:	No

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