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Details for New Drug Application (NDA): 009218

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NDA 009218 describes COUMADIN, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from seven suppliers. Additional details are available on the COUMADIN profile page.

The generic ingredient in COUMADIN is warfarin sodium. There are twenty-one drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

Summary for NDA: 009218

Bristol Myers Squibb
warfarin sodium
Therapeutic Class:Blood Products/Modifiers/ Volume Expanders
Formulation / Manufacturing:see details

Pharmacology for NDA: 009218

Mechanism of ActionVitamin K Inhibitors

Suppliers and Packaging for NDA: 009218

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
warfarin sodium
INJECTABLE;INJECTION 009218 NDA Bristol-Myers Squibb Pharma Company 0056-0168 0056-0168-01 10 TABLET in 1 BLISTER PACK (0056-0168-01)
warfarin sodium
INJECTABLE;INJECTION 009218 NDA Bristol-Myers Squibb Pharma Company 0056-0168 0056-0168-70 1 BOTTLE in 1 CARTON (0056-0168-70) > 100 TABLET in 1 BOTTLE

Summary for product number 005

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 007

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 012

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength75MG/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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