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Details for New Drug Application (NDA): 076110

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NDA 076110 describes TORSEMIDE, which is a drug marketed by West-ward Pharms Int, Teva, Vintage Pharms, Par Pharm, Hetero Labs Ltd Iii, Roxane, Pliva Pharm Ind, Aurobindo Pharma, Luitpold, Sun Pharm Inds, and Apotex Inc, and is included in eleven NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the torsemide profile page.

Summary for NDA: 076110

Tradename:
TORSEMIDE
Applicant:
Teva
Ingredient:
torsemide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076110

Suppliers and Packaging for NDA: 076110

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TORSEMIDE
torsemide
TABLET;ORAL 076110 ANDA Cardinal Health 55154-5057 55154-5057-0 1 BLISTER PACK in 1 BAG (55154-5057-0) > 10 TABLET in 1 BLISTER PACK
TORSEMIDE
torsemide
TABLET;ORAL 076110 ANDA Cardinal Health 55154-5667 55154-5667-0 1 BLISTER PACK in 1 BAG (55154-5667-0) > 10 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 14, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 14, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 14, 2002TE:ABRLD:No


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