Details for New Drug Application (NDA): 076943

NDA 076943 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 076943

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

Pharmacology for NDA: 076943

Physiological Effect

Increased Diuresis at Loop of Henle

Suppliers and Packaging for NDA: 076943

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TORSEMIDE	torsemide	TABLET;ORAL	076943	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0077	0054-0077-25	100 TABLET in 1 BOTTLE, PLASTIC (0054-0077-25)
TORSEMIDE	torsemide	TABLET;ORAL	076943	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0077	0054-0077-29	500 TABLET in 1 BOTTLE, PLASTIC (0054-0077-29)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 1, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 1, 2005	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Mar 1, 2005	TE:	AB	RLD:	No

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