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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091095

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NDA 091095 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 091095

Tradename:	NITROFURANTOIN
Applicant:	Actavis Labs Fl Inc
Ingredient:	nitrofurantoin, macrocrystalline
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Jun 18, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jun 18, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jun 18, 2015	TE:		RLD:	No

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