Last Updated: November 8, 2026

Details for New Drug Application (NDA): 201355

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NDA 201355 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Pharmobedient, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Annora Pharma, Aurobindo Pharma, Biocon Pharma, Novitium Pharma, Somerset Theraps Llc, Strides Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Chartwell Rx, Inventia, Micro Labs, Pharmazone, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-three NDAs. It is available from thirty-four suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 201355

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

Medical Subject Heading (MeSH) Categories for 201355

Anti-Infective Agents, Urinary

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	Aug 14, 2013	TE:	AB	RLD:	No

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