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Last Updated: January 23, 2021

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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. Fourteen 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
Paragraph IV (Patent) Challenges for 020136
Tradename Dosage Ingredient NDA Submissiondate
DEMADEX TABLET;ORAL torsemide 020136

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Aug 23, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Aug 23, 1993TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
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   Start Trial   Start Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993   Start Trial   Start Trial
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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