Product Details for NDA 020137
DEMADEX (TORSEMIDE)
50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: SOLUTION; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020137
Product Number: 002
Approval Date: Aug 23, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020137
Product Number: 002
Approval Date: Aug 23, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: SOLUTION; INTRAVENOUS
Strength: 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020137
Product Number: 001
Approval Date: Aug 23, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DEMADEX
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020137
Product Number: 001
Approval Date: Aug 23, 1993
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status: Discontinued
Patent and Exclusivity Information