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Serving leading biopharmaceutical companies globally:

Medtronic
Covington
Teva
McKinsey
Johnson and Johnson
Queensland Health
Farmers Insurance
Moodys
Chubb
Harvard Business School

Generated: October 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076363

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NDA 076363 describes DIGOXIN, which is a drug marketed by Hikma Intl Pharms, Hospira, Abraxis Pharm, West-ward Pharms Int, Impax Labs, Sun Pharm Inds Inc, Stevens J, Sandoz Inc, Mylan Pharms Inc, and Wyeth Ayerst, and is included in thirteen NDAs. It is available from thirty-two 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 suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for NDA: 076363

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076363

Ingredient-typeCardiac Glycosides

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 16714-590-01 100 TABLET in 1 BOTTLE (16714-590-01)
DIGOXIN
digoxin
TABLET;ORAL 076363 ANDA Northstar Rx LLC 16714-590 16714-590-02 1000 TABLET in 1 BOTTLE (16714-590-02)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Citi
Cipla
Accenture
Johnson and Johnson
Queensland Health
Merck
UBS
Mallinckrodt

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