Details for New Drug Application (NDA): 076894

NDA 076894 describes TORSEMIDE, which is a drug marketed by Am Regent, Hikma, Aurobindo Pharma, Corepharma, Hetero Labs Ltd Iii, Pliva Pharm Ind, Strides Pharma Intl, Sun Pharm Inds, and Teva, and is included in eleven NDAs. It is available from twenty-one suppliers. Additional details are available on the TORSEMIDE profile page.

The generic ingredient in TORSEMIDE is torsemide. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the torsemide profile page.

Summary for 076894

Tradename:	TORSEMIDE
Applicant:	Corepharma
Ingredient:	torsemide
Patents:	0

Pharmacology for NDA: 076894

Physiological Effect

Increased Diuresis at Loop of Henle

Suppliers and Packaging for NDA: 076894

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TORSEMIDE	torsemide	TABLET;ORAL	076894	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-871	23155-871-01	100 TABLET in 1 BOTTLE (23155-871-01)
TORSEMIDE	torsemide	TABLET;ORAL	076894	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-871	23155-871-05	500 TABLET in 1 BOTTLE (23155-871-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 31, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 31, 2005	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 31, 2005	TE:	AB	RLD:	No

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