Approved Drug Products containing Nitrofurantoin listed in the FDA Orange Book. Original Data : FDA Website

Applicant Active Ingredients Dosage Form Route Dosage Strength Proprietary Name RX/OTC/DISCN RLD TE Code Application Number Approval Date
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN MACROCRYSTALLINE DISCN No 70248 1988-06-24
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN MACROCRYSTALLINE DISCN No 70249 1988-06-24
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG NITROFURANTOIN DISCN No 73696 1992-12-31
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN DISCN No 73696 1992-12-31
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN DISCN No 73696 1992-12-31
Actavis Inc. NITROFURANTOIN TABLET;ORAL 50MG NITROFURANTOIN DISCN No 80447 1982-01-01
Actavis Inc. NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 80447 1982-01-01
Actavis Inc. NITROFURANTOIN CAPSULE;ORAL 50MG NITROFURANTOIN DISCN No 84326 1982-01-01
Actavis Inc. NITROFURANTOIN CAPSULE;ORAL 100MG NITROFURANTOIN DISCN No 84326 1982-01-01
Actavis Inc. NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 85796 1982-01-01
Actavis Inc. NITROFURANTOIN TABLET;ORAL 50MG NITROFURANTOIN DISCN No 85797 1982-01-01
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG NITROFURANTOIN RX No AB 91095 2015-06-18
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 91095 2015-06-18
Actavis Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 91095 2015-06-18
Actavis Inc. NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) RX No AB 202250 2015-07-08
Actavis Inc. NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML NITROFURANTOIN RX No AB 205180 2016-05-03
Alvogen NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG MACRODANTIN RX Yes AB 16620 1982-01-01
Alvogen NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG MACRODANTIN RX Yes AB 16620 1982-01-01
Alvogen NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG MACRODANTIN RX Yes AB 16620 1982-01-01
Alvogen NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG MACROBID RX Yes AB 20064 1991-12-24
Amneal Pharmaceuticals NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML NITROFURANTOIN RX No AB 201679 2011-05-11
Amneal Pharmaceuticals NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) RX No AB 207372 2017-05-15
DELCOR ASSET NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML FURADANTIN RX Yes AB 9175 1982-01-01
Impax Laboratories, Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 73652 1993-01-28
Impax Laboratories, Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 73671 1993-01-28
IVAX Pharmaceuticals Inc NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 80078 1982-01-01
IVAX Pharmaceuticals Inc NITROFURANTOIN TABLET;ORAL 50MG NITROFURANTOIN DISCN No 80078 1982-01-01
Lannett Company, Inc. NITROFURANTOIN TABLET;ORAL 50MG FURALAN DISCN No 80017 1982-01-01
Lannett Company, Inc. NITROFURANTOIN TABLET;ORAL 100MG FURALAN DISCN No 80017 1982-01-01
Mylan Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 74967 1997-07-09
Mylan Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN DISCN No 74967 1997-07-09
Mylan Inc. NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) RX No AB 76648 2004-03-22
Mylan Inc. NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 77025 2004-08-18
Nostrum Laboratories, Inc. NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML NITROFURANTOIN RX No AB 201355 2013-08-14
Novel Laboratories, Inc. NITROFURANTOIN SUSPENSION;ORAL 25MG/5ML NITROFURANTOIN RX No AB 201693 2014-09-08
PROCTER AND GAMBLE NITROFURANTOIN TABLET;ORAL 50MG FURADANTIN DISCN No 8693 1982-01-01
PROCTER AND GAMBLE NITROFURANTOIN TABLET;ORAL 100MG FURADANTIN DISCN No 8693 1982-01-01
RANBAXY LABORATORIES LIMITED NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) DISCN No 76951 2005-03-30
Sandoz Inc NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG NITROFURANTOIN DISCN No 74336 1995-01-25
Sandoz Inc NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN DISCN No 74336 1995-01-25
Sandoz Inc NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN DISCN No 74336 1995-01-25
Sandoz Inc NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) RX No AB 77066 2005-04-05
Sandoz Inc NITROFURANTOIN TABLET;ORAL 50MG NITROFURANTOIN DISCN No 80043 1982-01-01
Sandoz Inc NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 80043 1982-01-01
Sun Pharmaceutical Industries Limited NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 25MG NITROFURANTOIN RX No AB 201722 2016-02-16
Sun Pharmaceutical Industries Limited NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 201722 2016-02-16
Sun Pharmaceutical Industries Limited NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 201722 2016-02-16
ZYDUS PHARMS USA INC NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 205005 2017-12-12
ZYDUS PHARMS USA INC NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 205005 2017-12-12
ELKINS SINN
NITROFURANTOIN TABLET;ORAL 50MG NITROFURANTOIN DISCN No 80003 1982-01-01
ELKINS SINN
NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 80003 1982-01-01
WHITEWORTH TOWN PLSN
NITROFURANTOIN TABLET;ORAL 100MG NITROFURANTOIN DISCN No 84085 1982-01-01
NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 50MG NITROFURANTOIN RX No AB 203233 2018-07-09
NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 100MG NITROFURANTOIN RX No AB 203233 2018-07-09
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE CAPSULE;ORAL 75MG;25MG NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) RX No AB 208516 2018-05-24