BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
Cantor Fitzgerald
Queensland Health
Cerilliant
Chubb
Medtronic
Daiichi Sankyo
Merck
Julphar
Dow

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201679

« Back to Dashboard

NDA 201679 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Impax Labs Inc, Mylan, Sandoz, Sun Pharm Industries, Watson Labs, 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-seven 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 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 65162-689-88 230 mL in 1 BOTTLE, GLASS (65162-689-88)

Profile for product number 001

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Deloitte
Dow
Harvard Business School
McKesson
Fish and Richardson
Daiichi Sankyo
Argus Health
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot