Details for New Drug Application (NDA): 076346

NDA 076346 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 076346

Tradename:	TORSEMIDE
Applicant:	Pliva Pharm Ind
Ingredient:	torsemide
Patents:	0

Pharmacology for NDA: 076346

Physiological Effect

Increased Diuresis at Loop of Henle

Suppliers and Packaging for NDA: 076346

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TORSEMIDE	torsemide	TABLET;ORAL	076346	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8521	0615-8521-39	30 TABLET in 1 BLISTER PACK (0615-8521-39)
TORSEMIDE	torsemide	TABLET;ORAL	076346	ANDA	AvKARE	42291-816	42291-816-90	90 TABLET in 1 BOTTLE (42291-816-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 30, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 30, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 30, 2003	TE:	AB	RLD:	No

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