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Generated: November 18, 2018

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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. 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 020136
Tradename:DEMADEX
Applicant:Mylan Speciality Lp
Ingredient:torsemide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020136
Suppliers and Packaging for NDA: 020136
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMADEX torsemide TABLET;ORAL 020136 NDA Meda Pharmaceuticals 0037-3500 0037-3500-01 100 TABLET in 1 BOTTLE (0037-3500-01)
DEMADEX torsemide TABLET;ORAL 020136 NDA Meda Pharmaceuticals 0037-3510 0037-3510-01 100 TABLET in 1 BOTTLE (0037-3510-01)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 23, 1993TE:ABRLD: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 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-001 Aug 23, 1993 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-004 Aug 23, 1993 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 ➤ Sign Up ➤ Sign Up
Mylan Speciality Lp DEMADEX torsemide TABLET;ORAL 020136-003 Aug 23, 1993 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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