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Last Updated: June 13, 2024

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. Twelve suppliers are listed for this compound. Additional details are available on the nitrofurantoin profile page.
Summary for 009175
Applicant:Casper Pharma Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 009175
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 AUTHORIZED GENERIC Rising Pharma Holdings, Inc. 16571-740 16571-740-24 1 BOTTLE in 1 CARTON (16571-740-24) / 230 mL in 1 BOTTLE
FURADANTIN nitrofurantoin SUSPENSION;ORAL 009175 NDA AUTHORIZED GENERIC Rising Pharma Holdings, Inc. 16571-888 16571-888-06 1 BOTTLE in 1 CARTON (16571-888-06) / 60 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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength50MG/5ML
Approval Date:Jun 9, 2023TE:RLD:Yes

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