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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Farmers Insurance
Merck
UBS
Cipla
Accenture
US Army
Argus Health
Federal Trade Commission

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201679

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NDA 201679 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-four suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 201679
Tradename:NITROFURANTOIN
Applicant:Amneal Pharms
Ingredient:nitrofurantoin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201679
Ingredient-typeNitrofurans
Medical Subject Heading (MeSH) Categories for 201679
Suppliers and Packaging for NDA: 201679
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201679 ANDA Amneal Pharmaceuticals LLC 65162-689 N 65162-689-88

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:May 11, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Julphar
Colorcon
Deloitte
Cantor Fitzgerald
Argus Health
Chinese Patent Office
McKinsey
Covington

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