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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 077066


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NDA 077066 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 077066
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Sandoz
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 077066
Suppliers and Packaging for NDA: 077066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 077066 ANDA Sandoz Inc 0185-0122 0185-0122-01 100 CAPSULE in 1 BOTTLE (0185-0122-01)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 077066 ANDA Sandoz Inc 0185-0122 0185-0122-10 1000 CAPSULE in 1 BOTTLE (0185-0122-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Apr 5, 2005TE:ABRLD:No

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Preferred Citation:

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