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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020136


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NDA 020136 describes DEMADEX, which is a drug marketed by Roche and Mylan Speciality Lp and is included in two NDAs. Additional details are available on the DEMADEX profile page.

The generic ingredient in DEMADEX is torsemide. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the torsemide profile page.
Summary for 020136
Tradename:DEMADEX
Applicant:Mylan Speciality Lp
Ingredient:torsemide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 23, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 23, 1993TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 23, 1993TE:RLD:Yes

Expired US Patents for NDA 020136

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-002 Aug 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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