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Details for New Drug Application (NDA): 018413

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NDA 018413 describes FUROSEMIDE, which is a drug marketed by Sun Pharm Inds, Fresenius Kabi Usa, Watson Labs, Abraxis Pharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Astrazeneca, Dava Pharms Inc, Marsam Pharms Llc, Organon Usa Inc, Warner Chilcott, Smith And Nephew, Roxane, Intl Medication, Emcure Pharms Ltd, Hospira, Eurohlth Intl Sarl, Wockhardt, Claris, Sandoz, Amneal Pharms Co, Sun Pharm Inds Inc, Kalapharm, Wyeth Ayerst, Superpharm, Luitpold, Mylan, Mutual Pharm, Leading Pharma Llc, Igi Labs Inc, and Vintage Pharms, and is included in fifty-seven NDAs. It is available from sixty-four suppliers. Additional details are available on the FUROSEMIDE profile page.

The generic ingredient in FUROSEMIDE is furosemide. There are twenty-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for NDA: 018413

Ivax Sub Teva Pharms
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 018413

Suppliers and Packaging for NDA: 018413

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 018413 NDA IVAX Pharmaceuticals, Inc. 0172-2907 0172-2907-60 100 TABLET in 1 BOTTLE (0172-2907-60)
TABLET;ORAL 018413 NDA IVAX Pharmaceuticals, Inc. 0172-2907 0172-2907-80 1000 TABLET in 1 BOTTLE (0172-2907-80)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Nov 30, 1983TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Nov 30, 1983TE:ABRLD:No

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