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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 212174


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NDA 212174 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, 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-four 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 212174
Tradename:FUROSEMIDE
Applicant:Eugia Pharma
Ingredient:furosemide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212174
Medical Subject Heading (MeSH) Categories for 212174
Suppliers and Packaging for NDA: 212174
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUROSEMIDE furosemide INJECTABLE;INJECTION 212174 ANDA Henry Schein, Inc. 0404-9864 0404-9864-02 1 VIAL in 1 BAG (0404-9864-02) / 2 mL in 1 VIAL
FUROSEMIDE furosemide INJECTABLE;INJECTION 212174 ANDA AuroMedics Pharma LLC 55150-322 55150-322-25 25 VIAL in 1 CARTON (55150-322-25) / 2 mL in 1 VIAL (55150-322-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:May 3, 2019TE:APRLD:No

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