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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 076363

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NDA 076363 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 are ten drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for 076363

Tradename:	DIGOXIN
Applicant:	Sun Pharm Inds Inc
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 076363

Medical Subject Heading (MeSH) Categories for 076363

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 076363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	TABLET;ORAL	076363	ANDA	Northstar Rx LLC	16714-590	16714-590-01	100 TABLET in 1 BOTTLE (16714-590-01)
DIGOXIN	digoxin	TABLET;ORAL	076363	ANDA	Northstar Rx LLC	16714-590	16714-590-02	1000 TABLET in 1 BOTTLE (16714-590-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Jan 31, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Jan 31, 2003	TE:	AB	RLD:	No

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