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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Harvard Business School
US Department of Justice
Julphar
Queensland Health
Cerilliant
Colorcon
UBS
Chubb

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 009175

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NDA 009175 describes FURADANTIN, which is a drug marketed by Casper Pharma Llc and Procter And Gamble and is included in two NDAs. It is available from three suppliers. Additional details are available on the FURADANTIN profile page.

The generic ingredient in FURADANTIN is nitrofurantoin. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nitrofurantoin profile page.
Summary for 009175
Tradename:FURADANTIN
Applicant:Casper Pharma Llc
Ingredient:nitrofurantoin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 009175
Ingredient-typeNitrofurans
Medical Subject Heading (MeSH) Categories for 009175
Suppliers and Packaging for NDA: 009175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FURADANTIN nitrofurantoin SUSPENSION;ORAL 009175 NDA Shionogi Inc. 59630-450 E 59630-450-08
FURADANTIN nitrofurantoin SUSPENSION;ORAL 009175 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-471 E 66993-471-73

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Chubb
Cerilliant
Teva
Deloitte
US Army
Federal Trade Commission
Baxter

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