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Last Updated: November 13, 2019

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Details for New Drug Application (NDA): 020137

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NDA 020137 describes DEMADEX, which is a drug marketed by Roche and Mylan Speciality Lp and is included in two NDAs. It is available from one supplier. 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. Fifteen suppliers are listed for this compound. Additional details are available on the torsemide profile page.
Summary for 020137
Tradename:DEMADEX
Applicant:Roche
Ingredient:torsemide
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 23, 1993TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 23, 1993TE:RLD:Yes

Expired US Patents for NDA 020137

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993   Start Trial   Start Trial
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993   Start Trial   Start Trial
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993   Start Trial   Start Trial
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993   Start Trial   Start Trial
Roche DEMADEX torsemide INJECTABLE;INJECTION 020137-002 Aug 23, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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