Last Updated: May 11, 2026

Details for New Drug Application (NDA): 074967

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NDA 074967 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, Creekwood Pharms, Inventia, Omsav Pharma, 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 twenty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 074967

Tradename:	NITROFURANTOIN
Applicant:	Aurobindo Pharma Usa
Ingredient:	nitrofurantoin, macrocrystalline
Patents:	0

Suppliers and Packaging for NDA: 074967

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	074967	ANDA	Aurobindo Pharma Limited	59651-753	59651-753-01	100 CAPSULE in 1 BOTTLE (59651-753-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jul 9, 1997	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 9, 1997	TE:	AB	RLD:	No

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