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Details for New Drug Application (NDA): 040282

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NDA 040282 describes DIGOXIN, which is a drug marketed by Hikma Intl Pharms, Hospira, Abraxis Pharm, Roxane, Impax Labs, Sun Pharm Inds Inc, Stevens J, Sandoz, Mylan Pharms Inc, Wyeth Ayerst, and Eurohlth Intl Sarl, and is included in thirteen NDAs. It is available from thirty-five 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 NDA: 040282

Tradename:
DIGOXIN
Applicant:
Mylan Pharms Inc
Ingredient:
digoxin
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040282

Ingredient-typeCardiac Glycosides

Suppliers and Packaging for NDA: 040282

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN
digoxin
TABLET;ORAL 040282 ANDA Mylan Pharmaceuticals Inc. 0378-6155 0378-6155-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-6155-01)
DIGOXIN
digoxin
TABLET;ORAL 040282 ANDA Mylan Pharmaceuticals Inc. 0378-6155 0378-6155-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-6155-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Dec 23, 1999TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Dec 23, 1999TE:ABRLD:No


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