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Generated: May 23, 2017

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Nitrofurantoin - Generic Drug Details

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What are the generic drug sources for nitrofurantoin and what is the scope of nitrofurantoin freedom to operate?

is the generic ingredient in eight branded drugs marketed by Elkins Sinn, Lannett, Watson Labs, Sandoz, Nostrum Labs Inc, Casper Pharma Llc, Ivax Sub Teva Pharms, Amneal Pharms, Actavis Mid Atlantic, Whiteworth Town Plsn, Novel Labs Inc, Procter And Gamble, Alvogen Malta, Sun Pharm Inds, Mylan, Impax Labs Inc, Actavis Labs Fl Inc, Watson Labs Inc, and Ranbaxy Labs Ltd, and is included in thirty-two NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for nitrofurantoin. Ten suppliers are listed for this compound.

Summary for Generic Name: nitrofurantoin

Drug Master File Entries: see list19
Suppliers / Packagers: see list10
Bulk Api Vendors: see list47
Clinical Trials: see list7
Patent Applications: see list6,331
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nitrofurantoin at DailyMed

Pharmacology for Ingredient: nitrofurantoin

Drug ClassNitrofuran Antibacterial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
nitrofurantoin; nitrofurantoin, macrocrystalline
CAPSULE;ORAL076648-001Mar 22, 2004ABRXNoNo► Subscribe► Subscribe
Alvogen Malta
nitrofurantoin; nitrofurantoin, macrocrystalline
CAPSULE;ORAL020064-001Dec 24, 1991ABRXYesYes► Subscribe► Subscribe
Nostrum Labs Inc
SUSPENSION;ORAL201355-001Aug 14, 2013ABRXNoNo► Subscribe► Subscribe
Watson Labs
nitrofurantoin, macrocrystalline
CAPSULE;ORAL070249-001Jun 24, 1988DISCNNoNo► Subscribe► Subscribe
TABLET;ORAL080017-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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