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Details for New Drug Application (NDA): 207552

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NDA 207552 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, West-ward Pharms Int, 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-two 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-four suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for NDA: 207552

Tradename:
FUROSEMIDE
Applicant:
Amneal Pharms Co
Ingredient:
furosemide
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 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 Biosciences 70121-1076 70121-1076-1 1 VIAL, GLASS in 1 CARTON (70121-1076-1) > 10 mL in 1 VIAL, GLASS
FUROSEMIDE
furosemide
INJECTABLE;INJECTION 207552 ANDA Amneal Biosciences 70121-1163 70121-1163-5 25 VIAL, GLASS in 1 CARTON (70121-1163-5) > 2 mL in 1 VIAL, GLASS (70121-1163-1)

Summary for product number 001

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


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