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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213000

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NDA 213000 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 213000

Tradename:	DIGOXIN
Applicant:	Vistapharm Llc
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 213000

Medical Subject Heading (MeSH) Categories for 213000

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 213000

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	ELIXIR;ORAL	213000	ANDA	VistaPharm, LLC	66689-327	66689-327-02	1 BOTTLE, GLASS in 1 CARTON (66689-327-02) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ELIXIR;ORAL			Strength	0.05MG/ML
Approval Date:	Oct 4, 2019	TE:	AA	RLD:	No

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