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Generated: December 15, 2017

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 two 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. Nine suppliers are listed for this compound. Additional details are available on the nitrofurantoin profile page.

Summary for 009175

Tradename:1
Applicant:1
Ingredient:1
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 59630-450-08 1 BOTTLE, GLASS in 1 CARTON (59630-450-08) > 230 mL in 1 BOTTLE, GLASS
FURADANTIN nitrofurantoin SUSPENSION;ORAL 009175 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-471 66993-471-73 1 BOTTLE, GLASS in 1 CARTON (66993-471-73) > 230 mL in 1 BOTTLE, GLASS

Summary 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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