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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 077002

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NDA 077002 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 077002

Tradename:	DIGOXIN
Applicant:	Hikma Intl Pharms
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 077002

Medical Subject Heading (MeSH) Categories for 077002

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 077002

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	TABLET;ORAL	077002	ANDA	Hikma Pharmaceuticals USA Inc.	0143-1240	0143-1240-01	100 TABLET in 1 BOTTLE, PLASTIC (0143-1240-01)
DIGOXIN	digoxin	TABLET;ORAL	077002	ANDA	Hikma Pharmaceuticals USA Inc.	0143-1240	0143-1240-10	1000 TABLET in 1 BOTTLE, PLASTIC (0143-1240-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Oct 30, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Oct 30, 2007	TE:	AB	RLD:	No

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