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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 201693

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NDA 201693 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-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 201693

Tradename:	NITROFURANTOIN
Applicant:	Novel Labs Inc
Ingredient:	nitrofurantoin
Patents:	0

Pharmacology for NDA: 201693

Medical Subject Heading (MeSH) Categories for 201693

Anti-Infective Agents, Urinary

Suppliers and Packaging for NDA: 201693

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	201693	ANDA	Novel Laboratories, Inc.	40032-450	40032-450-11	1 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLE
NITROFURANTOIN	nitrofurantoin	SUSPENSION;ORAL	201693	ANDA	Lupin Pharmaceuticals,Inc.	43386-450	43386-450-11	1 BOTTLE in 1 CARTON (43386-450-11) / 230 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	Sep 8, 2014	TE:	AB	RLD:	No

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