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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 207372


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NDA 207372 describes NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), which is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in eleven NDAs. It is available from twenty-eight suppliers. Additional details are available on the NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) profile page.

The generic ingredient in NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) 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 207372
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Amneal Pharms
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 207372
Suppliers and Packaging for NDA: 207372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 207372 ANDA AvPAK 50268-625 50268-625-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-625-15) / 1 CAPSULE in 1 BLISTER PACK (50268-625-11)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 207372 ANDA American Health Packaging 60687-633 60687-633-01 100 BLISTER PACK in 1 CARTON (60687-633-01) / 1 CAPSULE in 1 BLISTER PACK (60687-633-11)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:May 15, 2017TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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