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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Covington
Fish and Richardson
Cerilliant
Healthtrust
Baxter
Teva
Dow
AstraZeneca

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077002

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NDA 077002 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-two suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 077002
Tradename:DIGOXIN
Applicant:Hikma Intl Pharms
Ingredient:digoxin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077002
Ingredient-typeCardiac Glycosides
Medical Subject Heading (MeSH) Categories for 077002
Suppliers and Packaging for NDA: 077002
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin TABLET;ORAL 077002 ANDA West-Ward Pharmaceuticals Corp 0143-1240 N 0143-1240-51
DIGOXIN digoxin TABLET;ORAL 077002 ANDA West-Ward Pharmaceuticals Corp 0143-1240 N 0143-1240-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 30, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Oct 30, 2007TE:ABRLD:No

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Federal Trade Commission
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Johnson and Johnson
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