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Last Updated: August 3, 2020

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Nitrofurantoin, macrocrystalline - Generic Drug Details

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What are the generic drug sources for nitrofurantoin, macrocrystalline and what is the scope of patent protection?

Nitrofurantoin, macrocrystalline is the generic ingredient in three branded drugs marketed by Alvogen, Actavis Labs Fl Inc, Impax Labs Inc, Invatech, Mylan, Novel Labs Inc, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty suppliers are listed for this compound.

Summary for nitrofurantoin, macrocrystalline
Recent Clinical Trials for nitrofurantoin, macrocrystalline

Identify potential brand extensions & 505(b)(2) entrants

University of California, San DiegoN/A
Vanderbilt UniversityPhase 4
Mayo ClinicPhase 4

See all nitrofurantoin, macrocrystalline clinical trials

Pharmacology for nitrofurantoin, macrocrystalline

US Patents and Regulatory Information for nitrofurantoin, macrocrystalline

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novel Labs Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 203233-002 Jul 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 205005-001 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073696-001 Dec 31, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025-001 Aug 18, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs NITROFURANTOIN MACROCRYSTALLINE nitrofurantoin, macrocrystalline CAPSULE;ORAL 070248-001 Jun 24, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 201722-002 Feb 16, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Invatech NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 074336-001 Jan 25, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Harvard Business School

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