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Details for New Drug Application (NDA): 079234

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NDA 079234 describes TORSEMIDE, which is a drug marketed by Eurohlth Intl Sarl, 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 nineteen 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 suppliers are listed for this compound. Additional details are available on the torsemide profile page.

Summary for NDA: 079234

Hetero Labs Ltd Iii
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 079234

Suppliers and Packaging for NDA: 079234

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
TABLET;ORAL 079234 ANDA Camber Pharmaceuticals, Inc. 31722-529 31722-529-01 12 BOTTLE in 1 CASE (31722-529-01) > 100 TABLET in 1 BOTTLE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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