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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207552


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NDA 207552 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 207552
Tradename:FUROSEMIDE
Applicant:Amneal Pharms Co
Ingredient:furosemide
Patents:0
Pharmacology for NDA: 207552
Medical Subject Heading (MeSH) Categories for 207552
Suppliers and Packaging for NDA: 207552
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUROSEMIDE furosemide INJECTABLE;INJECTION 207552 ANDA Amneal Pharmaceuticals LLC 70121-1076 70121-1076-5 25 VIAL, GLASS in 1 CARTON (70121-1076-5) / 10 mL in 1 VIAL, GLASS (70121-1076-1)
FUROSEMIDE furosemide INJECTABLE;INJECTION 207552 ANDA Amneal Pharmaceuticals LLC 70121-1163 70121-1163-5 25 VIAL, GLASS in 1 CARTON (70121-1163-5) / 2 mL in 1 VIAL, GLASS (70121-1163-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jul 20, 2016TE:APRLD:No

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