Details for New Drug Application (NDA): 078249

NDA 078249 describes TORSEMIDE, which is a drug marketed by Am Regent, West-ward Pharms Int, Aurobindo Pharma, Heritage, Hetero Labs Ltd Iii, Hikma, Pliva Pharm Ind, Strides Pharma, Sun Pharm Inds, and Teva, and is included in eleven NDAs. It is available from twenty 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-one suppliers are listed for this compound. Additional details are available on the torsemide profile page.

Summary for 078249

Tradename:	TORSEMIDE
Applicant:	Aurobindo Pharma
Ingredient:	torsemide
Patents:	0

Pharmacology for NDA: 078249

Physiological Effect

Increased Diuresis at Loop of Henle

Suppliers and Packaging for NDA: 078249

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TORSEMIDE	torsemide	TABLET;ORAL	078249	ANDA	Rising Pharma Holdings, Inc.	57237-138	57237-138-01	100 TABLET in 1 BOTTLE (57237-138-01)
TORSEMIDE	torsemide	TABLET;ORAL	078249	ANDA	Rising Pharma Holdings, Inc.	57237-139	57237-139-01	100 TABLET in 1 BOTTLE (57237-139-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 17, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 17, 2007	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 17, 2007	TE:	AB	RLD:	No

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