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. Eighteen 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:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 23, 1993	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 23, 1993	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Aug 23, 1993	TE:		RLD:	Yes

Expired US Patents for NDA 020136

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-003	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	020136-001	Aug 23, 1993	⤷ Try a Trial	⤷ Try a Trial
Mylan Speciality Lp	DEMADEX	torsemide	TABLET;ORAL	020136-003	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	020136-003	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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