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Generated: November 14, 2018

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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. Eight 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
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 Casper Pharma LLC 70199-006 70199-006-32 1 BOTTLE in 1 CARTON (70199-006-32) > 230 mL in 1 BOTTLE

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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