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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078007

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NDA 078007 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 078007

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/2ML (10MG/ML)
Approval Date:	Jun 11, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Jun 11, 2008	TE:		RLD:	No

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