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Federal Trade Commission
Fish and Richardson
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UBS
Dow
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AstraZeneca
Cantor Fitzgerald
Merck

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076363

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NDA 076363 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 twenty-nine 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-seven suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 076363
Tradename:DIGOXIN
Applicant:Sun Pharm Inds Inc
Ingredient:digoxin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076363
Ingredient-typeCardiac Glycosides
Medical Subject Heading (MeSH) Categories for 076363
Suppliers and Packaging for NDA: 076363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin TABLET;ORAL 076363 ANDA Northstar Rx LLC 16714-590 N 16714-590-01
DIGOXIN digoxin TABLET;ORAL 076363 ANDA Northstar Rx LLC 16714-590 N 16714-590-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jan 31, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jan 31, 2003TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Argus Health
Covington
Chinese Patent Office
Accenture
Cipla
Johnson and Johnson
Citi
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