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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205180

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NDA 205180 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, 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, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in forty-two NDAs. It is available from thirty-five 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. Twenty-nine suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 205180

Tradename:	NITROFURANTOIN
Applicant:	Actavis Mid Atlantic
Ingredient:	nitrofurantoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 205180

Anti-Infective Agents, Urinary

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	May 3, 2016	TE:	AB	RLD:	No

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