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Generated: April 27, 2017

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Details for New Drug Application (NDA): 020405

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NDA 020405 describes LANOXIN, which is a drug marketed by Concordia Pharms Inc and Covis Pharma Sarl and is included in two NDAs. It is available from eleven 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. Forty-one suppliers are listed for this compound. Additional details are available on the digoxin profile page.

Summary for NDA: 020405

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020405

Ingredient-typeCardiac Glycosides

Suppliers and Packaging for NDA: 020405

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 020405 NDA AUTHORIZED GENERIC NCS HealthCare of KY, Inc dba Vangard Labs 0615-7935 0615-7935-14 14 TABLET in 1 BLISTER PACK (0615-7935-14)
TABLET;ORAL 020405 NDA AUTHORIZED GENERIC NCS HealthCare of KY, Inc dba Vangard Labs 0615-7935 0615-7935-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7935-30) > 5 TABLET in 1 BLISTER PACK

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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