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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 211013


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NDA 211013 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-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-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 211013
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Inventia
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 211013
Suppliers and Packaging for NDA: 211013
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 211013 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8531 0615-8531-10 10 CAPSULE in 1 BLISTER PACK (0615-8531-10)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 211013 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8531 0615-8531-14 14 CAPSULE in 1 BLISTER PACK (0615-8531-14)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Feb 18, 2022TE:ABRLD:No

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Preferred Citation:

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