You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078556

✉ Email this page to a colleague

« Back to Dashboard

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-eight 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-one 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.