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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 020405


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NDA 020405 describes LANOXIN, which is a drug marketed by Covis and Concordia and is included in two NDAs. It is available from three suppliers. Additional details are available on the LANOXIN profile page.

The generic ingredient in LANOXIN is digoxin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the digoxin profile page.
Summary for 020405
Tradename:LANOXIN
Applicant:Concordia
Ingredient:digoxin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020405
Medical Subject Heading (MeSH) Categories for 020405
Suppliers and Packaging for NDA: 020405
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANOXIN digoxin TABLET;ORAL 020405 NDA Concordia Pharmaceuticals Inc. 59212-240 59212-240-55 100 TABLET in 1 BOTTLE (59212-240-55)
LANOXIN digoxin TABLET;ORAL 020405 NDA Concordia Pharmaceuticals Inc. 59212-242 59212-242-55 100 TABLET in 1 BOTTLE (59212-242-55)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.0625MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.125MG
Approval Date:Sep 30, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.1875MG
Approval Date:Sep 30, 1997TE:RLD:Yes

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