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Details for New Drug Application (NDA): 090656

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NDA 090656 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: 090656

Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 090656

Suppliers and Packaging for NDA: 090656

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 090656 ANDA American Regent, Inc. 0517-0770 0517-0770-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-0770-10) > 2 mL in 1 VIAL, SINGLE-DOSE (0517-0770-01)
INJECTABLE;INJECTION 090656 ANDA American Regent, Inc. 0517-0771 0517-0771-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-0771-10) > 5 mL in 1 VIAL, SINGLE-DOSE (0517-0771-01)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Apr 21, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/5ML (10MG/ML)
Approval Date:Apr 21, 2010TE:RLD:No

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