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Serving leading biopharmaceutical companies globally:

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Generated: November 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201679

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NDA 201679 describes NITROFURANTOIN, which is a drug marketed by Elkins Sinn, Sun Pharm Inds, Mylan, Watson Labs, Sandoz, Impax Labs Inc, Nostrum Labs Inc, Ivax Sub Teva Pharms, Amneal Pharms, Actavis Mid Atlantic, Whiteworth Town Plsn, Novel Labs Inc, Actavis Labs Fl Inc, Watson Labs Inc, and Ranbaxy Labs Ltd, and is included in twenty-seven NDAs. It is available from twenty-four 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-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 201679

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 201679

Ingredient-typeNitrofurans

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)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Chinese Patent Office
Colorcon
Johnson and Johnson
Fuji
Farmers Insurance
Harvard Business School
Novartis
Chubb
Moodys

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.

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