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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 085796

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NDA 085796 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 085796

Tradename:	NITROFURANTOIN
Applicant:	Watson Labs
Ingredient:	nitrofurantoin
Patents:	0

Medical Subject Heading (MeSH) Categories for 085796

Anti-Infective Agents, Urinary

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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