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Last Updated: August 7, 2020

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NITROFURANTOIN, MACROCRYSTALLINE - Generic Drug Details

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

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

SponsorPhase
University of California, San DiegoN/A
University of British ColumbiaPhase 4
Duke UniversityPhase 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
Watson Labs NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073696-001 Dec 31, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 091095-002 Jun 18, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073652-001 Jan 28, 1993 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073671-001 Jan 28, 1993 AB RX 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:

McKesson
Harvard Business School
Johnson and Johnson
Baxter
Dow
Mallinckrodt

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