Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
AstraZeneca
Colorcon
Harvard Business School
Dow

Last Updated: June 25, 2022

Details for New Drug Application (NDA): 076268


✉ Email this page to a colleague

« Back to Dashboard

NDA 076268 describes DIGOXIN, which is a drug marketed by Amici, Hikma, Novitium Pharma, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, 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 076268
Tradename:DIGOXIN
Applicant:Stevens J
Ingredient:digoxin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076268
Medical Subject Heading (MeSH) Categories for 076268
Suppliers and Packaging for NDA: 076268
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin TABLET;ORAL 076268 ANDA Lannett Company, Inc. 0527-1324 0527-1324-01 100 TABLET in 1 BOTTLE (0527-1324-01)
DIGOXIN digoxin TABLET;ORAL 076268 ANDA Lannett Company, Inc. 0527-1324 0527-1324-10 1000 TABLET in 1 BOTTLE (0527-1324-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 26, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 26, 2002TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
Baxter
Merck
McKinsey
McKesson

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. 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.