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Federal Trade Commission
Colorcon
Citi
QuintilesIMS
US Army
Argus Health
Fuji
Deloitte
Julphar
Cantor Fitzgerald

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073671

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NDA 073671 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Impax Labs Inc, Mylan, Sandoz, Sun Pharm Industries, Watson Labs, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Nostrum Labs Inc, Novel Labs Inc, Elkins Sinn, Ivax Sub Teva Pharms, Whiteworth Town Plsn, Ranbaxy Labs Ltd, and Watson Labs Inc, and is included in twenty-eight NDAs. It is available from twenty-six 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-three suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 073671
Tradename:NITROFURANTOIN
Applicant:Impax Labs Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 073671
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 073671
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073671 ANDA Impax Generics 0115-1643 N 0115-1643-01
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073671 ANDA Impax Generics 0115-1643 N 0115-1643-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jan 28, 1993TE:ABRLD:No

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