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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079234

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NDA 079234 describes TORSEMIDE, which is a drug marketed by Am Regent, West-ward Pharms Int, Aurobindo Pharma, Corepharma, Hetero Labs Ltd Iii, Hikma Pharms, Par Pharm, Pliva Pharm Ind, Sun Pharm Inds, Teva, and Vintage Pharms, and is included in eleven NDAs. It is available from fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the torsemide profile page.
Summary for 079234
Applicant:Hetero Labs Ltd Iii
Formulation / Manufacturing:see details
Pharmacology for NDA: 079234
Suppliers and Packaging for NDA: 079234
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TORSEMIDE torsemide TABLET;ORAL 079234 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7997 0615-7997-39 30 TABLET in 1 BLISTER PACK (0615-7997-39)
TORSEMIDE torsemide TABLET;ORAL 079234 ANDA Camber Pharmaceuticals, Inc. 31722-529 31722-529-01 100 TABLET in 1 BOTTLE (31722-529-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 27, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 27, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 27, 2009TE:ABRLD:No

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