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Last Updated: November 4, 2024

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 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.

Summary for NITROFURANTOIN, MACROCRYSTALLINE
Recent Clinical Trials for NITROFURANTOIN, MACROCRYSTALLINE

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

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

See all NITROFURANTOIN, MACROCRYSTALLINE clinical trials

Pharmacology for NITROFURANTOIN, MACROCRYSTALLINE
Anatomical Therapeutic Chemical (ATC) Classes 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
Sun Pharm Industries NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 201722-001 Feb 16, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025-002 Oct 2, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Usa NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 074967-001 Jul 9, 1997 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 211935-001 Jun 25, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Impax Labs Inc NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073671-001 Jan 28, 1993 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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