Last Updated: June 17, 2026

Details for New Drug Application (NDA): 073652

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NDA 073652 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Pom Pharma, 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 073652

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

Pharmacology for NDA: 073652

Suppliers and Packaging for NDA: 073652

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	073652	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1645	0115-1645-01	100 CAPSULE in 1 BOTTLE (0115-1645-01)
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	073652	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1645	0115-1645-03	1000 CAPSULE in 1 BOTTLE (0115-1645-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jan 28, 1993	TE:	AB	RLD:	No

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