Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 009218

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COUMADIN (WARFARIN SODIUM)
5MG/VIAL
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 024
Approval Date: Feb 7, 1995
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
50MG/VIAL
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 50MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 020
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
75MG/VIAL
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 75MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 012
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 022
Approval Date: Mar 1, 1990
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
2MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 013
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
2.5MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 018
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
3MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 025
Approval Date: Nov 18, 1996
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
4MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 023
Approval Date: Aug 24, 1993
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
5MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 007
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
6MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 026
Approval Date: Nov 18, 1996
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
7.5MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 016
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information

COUMADIN (WARFARIN SODIUM)
10MG
Marketing Status: Discontinued

Active Ingredient: WARFARIN SODIUM
Proprietary Name: COUMADIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N009218
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: BRISTOL MYERS SQUIBB PHARMA CO
Marketing Status:  Discontinued
Patent and Exclusivity Information