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Last Updated: June 25, 2022

Details for New Drug Application (NDA): 076268

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NDA 076268 describes DIGOXIN, which is a drug marketed by Amici, Hikma, Novitium Pharma, Abraxis Pharm, Hospira, Sandoz Inc, West-ward Pharms Int, Wyeth Ayerst, Aurobindo Pharma Ltd, Hikma Intl Pharms, Impax Labs, Rising, Stevens J, and Sun Pharm Inds Inc, and is included in seventeen NDAs. It is available from twenty-seven 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 suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 076268
Applicant:Stevens J
Formulation / Manufacturing:see details
Pharmacology for NDA: 076268
Medical Subject Heading (MeSH) Categories for 076268
Suppliers and Packaging for NDA: 076268
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIGOXIN digoxin TABLET;ORAL 076268 ANDA Lannett Company, Inc. 0527-1324 0527-1324-01 100 TABLET in 1 BOTTLE (0527-1324-01)
DIGOXIN digoxin TABLET;ORAL 076268 ANDA Lannett Company, Inc. 0527-1324 0527-1324-10 1000 TABLET in 1 BOTTLE (0527-1324-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Jul 26, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 26, 2002TE:ABRLD:No

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