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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Harvard Business School
Federal Trade Commission

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078556

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NDA 078556 describes DIGOXIN, which is a drug marketed by West-ward Pharms Int, Abraxis Pharm, Hospira, Sandoz Inc, Wyeth Ayerst, Hikma Intl Pharms, Impax Labs, Mylan Pharms Inc, Stevens J, and Sun Pharm Inds Inc, and is included in thirteen NDAs. It is available from thirty-three 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. Forty-one suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 078556
Applicant:Impax Labs
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078556
Ingredient-typeCardiac Glycosides
Medical Subject Heading (MeSH) Categories for 078556
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 Impax Generics 0115-9811 N 0115-9811-03
DIGOXIN digoxin TABLET;ORAL 078556 ANDA Impax Generics 0115-9811 N 0115-9811-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 20, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 20, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
US Army
Queensland Health

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