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Serving leading biopharmaceutical companies globally:

McKinsey
Covington
Chinese Patent Office
Baxter
Mallinckrodt
Harvard Business School
Medtronic
Healthtrust
McKesson
Chubb

Generated: February 22, 2018

DrugPatentWatch Database Preview

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, 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 201693
Tradename:NITROFURANTOIN
Applicant:Novel Labs Inc
Ingredient:nitrofurantoin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201693
Ingredient-typeNitrofurans
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 N 40032-450-11
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201693 ANDA Lupin Pharmaceuticals,Inc. 43386-450 N 43386-450-11

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Cerilliant
Cantor Fitzgerald
Boehringer Ingelheim
AstraZeneca
Baxter
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Dow

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