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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 218346

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NDA 218346 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, Annora Pharma, Appco, Aurobindo Pharma, Biocon Pharma, Novitium Pharma, Strides 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 forty-two NDAs. It is available from thirty-six 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-two suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 218346

Tradename:	NITROFURANTOIN
Applicant:	Biocon Pharma
Ingredient:	nitrofurantoin
Patents:	0

Pharmacology for NDA: 218346

Medical Subject Heading (MeSH) Categories for 218346

Anti-Infective Agents, Urinary

Suppliers and Packaging for NDA: 218346

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	218346	ANDA	Biocon Pharma Inc	70377-118	70377-118-31	1 BOTTLE, GLASS in 1 CARTON (70377-118-31) / 230 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	Oct 28, 2024	TE:	AB	RLD:	No

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