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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 018487


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NDA 018487 describes FUROSEMIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Am Regent, Amneal Pharms Co, Areva Pharms, Astrazeneca, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Meitheal, Saba Ilac Sanayive, Sagent, Smith And Nephew, Warner Chilcott, Watson Labs, Wockhardt, Wyeth Ayerst, Pharmobedient Cnsltg, Ani Pharms, Chartwell Rx, Epic Pharma Llc, Graviti Pharms, Ipca Labs Ltd, Kalapharm, Leading, Mylan, Prinston Inc, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Watson Labs Teva, and is included in sixty-five NDAs. It is available from fifty-four suppliers. Additional details are available on the FUROSEMIDE profile page.

The generic ingredient in FUROSEMIDE is furosemide. There are twenty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the furosemide profile page.
Summary for 018487
Tradename:FUROSEMIDE
Applicant:Mylan
Ingredient:furosemide
Patents:0
Pharmacology for NDA: 018487
Medical Subject Heading (MeSH) Categories for 018487
Suppliers and Packaging for NDA: 018487
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUROSEMIDE furosemide TABLET;ORAL 018487 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-341 43353-341-30 30 TABLET in 1 BOTTLE, PLASTIC (43353-341-30)
FUROSEMIDE furosemide TABLET;ORAL 018487 NDA Aphena Pharma Solutions - Tennessee, LLC 43353-341 43353-341-45 45 TABLET in 1 BOTTLE, PLASTIC (43353-341-45)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength40MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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