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Serving leading biopharmaceutical companies globally:

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Express Scripts
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077025

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NDA 077025 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-five 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-two suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for 077025

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

Pharmacology for NDA: 077025

Ingredient-typeNitrofurans

Suppliers and Packaging for NDA: 077025

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025 ANDA Mylan Pharmaceuticals Inc. 0378-1700 0378-1700-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-01)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025 ANDA Mylan Pharmaceuticals Inc. 0378-1700 0378-1700-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 18, 2004TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
Colorcon
Teva
Chinese Patent Office
Harvard Business School
Chubb
QuintilesIMS
Dow
Farmers Insurance
McKesson

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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