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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 201693


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NDA 201693 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, Inventia, Omsav Pharma, 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-four suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 201693
Tradename:NITROFURANTOIN
Applicant:Novel Labs Inc
Ingredient:nitrofurantoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201693
Medical Subject Heading (MeSH) Categories for 201693
Suppliers and Packaging for NDA: 201693
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201693 ANDA Novel Laboratories, Inc. 40032-450 40032-450-11 1 BOTTLE in 1 CARTON (40032-450-11) / 230 mL in 1 BOTTLE
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201693 ANDA Lupin Pharmaceuticals,Inc. 43386-450 43386-450-11 1 BOTTLE in 1 CARTON (43386-450-11) / 230 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Sep 8, 2014TE:ABRLD:No

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