Product Details for NDA 007883
ANTABUSE (DISULFIRAM)
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DISULFIRAM
Proprietary Name: ANTABUSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007883
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ANTABUSE (DISULFIRAM)
Proprietary Name: ANTABUSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007883
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: DISULFIRAM
Proprietary Name: ANTABUSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007883
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ANTABUSE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N007883
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status: Discontinued
Patent and Exclusivity Information