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Generated: April 24, 2017

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Details for New Drug Application (NDA): 018579

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NDA 018579 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, West-ward Pharms Int, Intl Medication, Emcure Pharms Ltd, Hospira, 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 Prinston Inc, and is included in fifty-seven NDAs. It is available from sixty 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-two suppliers are listed for this compound. Additional details are available on the furosemide profile page.

Summary for NDA: 018579

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018579

Suppliers and Packaging for NDA: 018579

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FUROSEMIDE
furosemide
INJECTABLE;INJECTION 018579 ANDA Rebel Distributors Corp 21695-721 21695-721-25 25 VIAL, SINGLE-DOSE in 1 BOX (21695-721-25) > 2 mL in 1 VIAL, SINGLE-DOSE
FUROSEMIDE
furosemide
INJECTABLE;INJECTION 018579 ANDA Physicians Total Care, Inc. 54868-2299 54868-2299-0 25 VIAL, SINGLE-DOSE in 1 TRAY (54868-2299-0) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 30, 1983TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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