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FURADANTIN

NDA

NITROFURANTOIN | N008693 | PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain26 active DMFs6 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN & NITROFURANTOIN MACROCRYSTALS

DMF 4531965

FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN MONOHYDRATE

DMF 132661998

TAPI NL BVNITROFURANTOIN MACROCRYSTALS USP

DMF 155042001

TAPI NL BVNITROFURANTOIN MONOHYDRATE USP

DMF 165052003

FIS FABBRICA ITALIANA SINTETICI SPANITROFURANTOIN MONOHYDRATE (CODE 1042-1026)

DMF 218872008

UNIMARK REMEDIES LTDNITROFURANTOIN ANHYDROUS USP

DMF 235002010

UNIMARK REMEDIES LTDNITROFURANTOIN MONOHYDRATE USP

DMF 235012010

UNIMARK REMEDIES LTDNITROFURANTOIN ANHYDROUS CRYSTALS USP

DMF 235702010

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDNITROFURANTOIN MACROCRYSTALS

DMF 246452011

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDNITROFURANTOIN

DMF 249802011

UNIMARK REMEDIES LTDNITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)

DMF 261762012

MACLEODS PHARMACEUTICALS LTDNITROFURANTOIN MONOHYDRATE

DMF 302852016

MACLEODS PHARMACEUTICALS LTDNITROFURANTOIN ANHYDROUS (MACROCRYSTAL)

DMF 307552016

MANKIND PHARMA LTDNITROFURANTOIN MONOHYDRATE USP

DMF 333512018

MANKIND PHARMA LTDNITROFURANTOIN MACROCRYSTALS USP

DMF 335232019

FERMION OYNITROFURANTOIN MONOHYDRATE

DMF 338382019

FERMION OYNITROFURANTOIN MACROCRYSTAL

DMF 338392019

MAITHRI DRUGS PRIVATE LTDNITROFURANTOIN HYDROUS USP

DMF 338772019

MAITHRI DRUGS PRIVATE LTDNITROFURANTOIN ANHYDROUS USP

DMF 341792019

MAITHRI DRUGS PRIVATE LTDNITROFURANTOIN ANHYDROUS USP (MACROCRYSTALS)

DMF 346312020

OMSAV PHARMA RESEARCH PRIVATE LTDNITROFURANTOIN MONOHYDRATE USP

DMF 363902021

OMSAV PHARMA RESEARCH PRIVATE LTDNITROFURANTOIN MACROCRYSTALS USP

DMF 363912021

ALEMBIC PHARMACEUTICALS LTDNITROFURANTOIN MONOHYDRATE USP

DMF 367842022

ALEMBIC PHARMACEUTICALS LTDNITROFURANTOIN MACROCRYSTAL USP

DMF 372462022

ASOLUTION PHARMACEUTICALS PVT LTDNITROFURANTOIN MONOHYDRATE

DMF 380792023

ASOLUTION PHARMACEUTICALS PVT LTDNITROFURANTOIN MACROCRYSTALS

DMF 380802023

PRODOTTI CHIMICI DOTTORI REInactiveNITROFURANTOIN

DMF 4541961

GEMA SAInactiveNITROFURANTOIN U.S.P

DMF 17331971

CAMBREX PROFARMACO MILANO SRLInactiveNITROFURANTOIN ANHYDROUS

DMF 18601972

CAMBREX PROFARMACO MILANO SRLInactiveNITROFURANTOIN MONOHYDRATE

DMF 18611972

BOEHRINGER MANNHEIM GMBHInactiveNITROFURANTOIN MACROCRYSTALLINE

DMF 79791989

JINAN JINDA PHARMACEUTICAL CHEMISTRY CO LTDInactiveNITROFURANTOIN MONOHYDRATE

DMF 249782011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982