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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215307

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NDA 215307 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 215307

Tradename:	DIGOXIN
Applicant:	Novitium Pharma
Ingredient:	digoxin
Patents:	0

Pharmacology for NDA: 215307

Medical Subject Heading (MeSH) Categories for 215307

Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 215307

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DIGOXIN	digoxin	TABLET;ORAL	215307	ANDA	Marlex Pharmaceuticals, Inc.	10135-747	10135-747-01	100 TABLET in 1 BOTTLE (10135-747-01)
DIGOXIN	digoxin	TABLET;ORAL	215307	ANDA	Marlex Pharmaceuticals, Inc.	10135-747	10135-747-10	1000 TABLET in 1 BOTTLE (10135-747-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.125MG
Approval Date:	Nov 22, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Nov 22, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.0625MG
Approval Date:	Aug 25, 2022	TE:	AB	RLD:	No

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