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Last Updated: March 29, 2024

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 Almatica, Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, and Zydus Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

Recent Clinical Trials for nitrofurantoin, macrocrystalline

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

SponsorPhase
MJM BontenPhase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
SaltroPhase 3

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
Aurobindo Pharma Usa NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 074967-002 Jul 9, 1997 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 217272-002 Mar 21, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073696-002 Dec 31, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Athem NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 074336-002 Jan 25, 1995 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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