Last Updated: May 3, 2026

Details for New Drug Application (NDA): 217357


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NDA 217357 describes NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), which is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Creekwood Pharms, Inventia, Mankind Pharma, Omsav Pharma, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in twelve NDAs. It is available from twenty-seven 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 suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 217357
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Mankind Pharma
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 217357
Suppliers and Packaging for NDA: 217357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357 ANDA Major Pharmaceuticals 0904-7571 0904-7571-61 100 BLISTER PACK in 1 CARTON (0904-7571-61) / 1 CAPSULE in 1 BLISTER PACK
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357 ANDA Coupler LLC 67046-1271 67046-1271-3 30 CAPSULE in 1 BLISTER PACK (67046-1271-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Jul 11, 2023TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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