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Last Updated: January 29, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078249


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NDA 078249 describes TORSEMIDE, which is a drug marketed by Am Regent, West-ward Pharms Int, Aurobindo Pharma, Corepharma, 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 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 078249
Tradename:TORSEMIDE
Applicant:Aurobindo Pharma
Ingredient:torsemide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078249
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 Health, LLC 57237-138 57237-138-01 100 TABLET in 1 BOTTLE (57237-138-01)
TORSEMIDE torsemide TABLET;ORAL 078249 ANDA Rising Health, LLC 57237-139 57237-139-01 100 TABLET in 1 BOTTLE (57237-139-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 17, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 17, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 17, 2007TE:ABRLD:No

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