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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203233

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NDA 203233 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 203233

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

Pharmacology for NDA: 203233

Suppliers and Packaging for NDA: 203233

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	203233	ANDA	Lupin Pharmaceuticals,Inc.	43386-641	43386-641-01	100 CAPSULE in 1 BOTTLE (43386-641-01)
NITROFURANTOIN	nitrofurantoin, macrocrystalline	CAPSULE;ORAL	203233	ANDA	Lupin Pharmaceuticals,Inc.	43386-642	43386-642-01	100 CAPSULE in 1 BOTTLE (43386-642-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50MG
Approval Date:	Jul 9, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Jul 9, 2018	TE:	AB	RLD:	No

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