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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020136

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DEMADEX (TORSEMIDE)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEMADEX (TORSEMIDE)
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: MYLAN SPECIALTY LP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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