Product Details for NDA 020136
DEMADEX (TORSEMIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TORSEMIDE
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020136
Product Number: 001
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020136
Product Number: 001
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TORSEMIDE
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020136
Product Number: 002
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N020136
Product Number: 002
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TORSEMIDE
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **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: N020136
Product Number: 003
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **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: N020136
Product Number: 003
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: TORSEMIDE
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **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: N020136
Product Number: 004
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG **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: N020136
Product Number: 004
Approval Date: Aug 23, 1993
Applicant Holder Full Name: NORVIUM BIOSCIENCE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information