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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-one suppliers are listed for this compound. Additional details are available on the warfarin sodium profile page.

Summary for NDA: 009218

Tradename:
COUMADIN
Applicant:
Bristol Myers Squibb
Ingredient:
warfarin sodium
Patents:0
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
COUMADIN
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)
COUMADIN
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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