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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 212607


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NDA 212607 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Inventia, Micro Labs, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in thirty-nine NDAs. It is available from thirty-two suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 212607
Tradename:NITROFURANTOIN
Applicant:Aurobindo Pharma
Ingredient:nitrofurantoin
Patents:0
Pharmacology for NDA: 212607
Medical Subject Heading (MeSH) Categories for 212607
Suppliers and Packaging for NDA: 212607
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 212607 ANDA Aurobindo Pharma Limited 59651-206 59651-206-23 1 BOTTLE in 1 CARTON (59651-206-23) / 230 mL in 1 BOTTLE
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 212607 ANDA Rising Pharma Holdings, Inc. 64980-593 64980-593-24 1 BOTTLE in 1 CARTON (64980-593-24) / 230 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:May 11, 2023TE:ABRLD:No

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