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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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Boehringer Ingelheim

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201355

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NDA 201355 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 201355
Applicant:Nostrum Labs Inc
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201355
Medical Subject Heading (MeSH) Categories for 201355
Suppliers and Packaging for NDA: 201355
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201355 ANDA Nostrum Laboratories, Inc. 70408-239 N 70408-239-32
NITROFURANTOIN nitrofurantoin SUSPENSION;ORAL 201355 ANDA Nostrum Laboratories, Inc. 70408-239 N 70408-239-34

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Aug 14, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Cantor Fitzgerald
Chinese Patent Office

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