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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211935


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NDA 211935 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, Aurobindo Pharma, Nostrum Labs Inc, Novitium 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 thirty-nine NDAs. It is available from thirty-two 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-five suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 211935
Tradename:NITROFURANTOIN
Applicant:Alembic
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 211935
Suppliers and Packaging for NDA: 211935
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 211935 ANDA Alembic Pharmaceuticals Limited 46708-389 46708-389-31 100 CAPSULE in 1 BOTTLE (46708-389-31)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 211935 ANDA Alembic Pharmaceuticals Limited 46708-389 46708-389-91 1000 CAPSULE in 1 BOTTLE (46708-389-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jun 25, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 25, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 25, 2021TE:ABRLD:No

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