FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
215272NDAORGANON LLC001VTAMACREAM;TOPICAL1%TAPINAROF2022-05-23PrescriptionYes
215650NDAORGANON LLC001XACIATOGEL;VAGINALEQ 2% BASECLINDAMYCIN PHOSPHATE2021-12-07PrescriptionYes
205641NDAORGANON LLC001ASMANEX HFAAEROSOL, METERED;INHALATION0.10MG/INHMOMETASONE FUROATE2014-04-25PrescriptionYes
002ASMANEX HFAAEROSOL, METERED;INHALATION0.20MG/INHMOMETASONE FUROATE2014-04-25PrescriptionYes
003ASMANEX HFAAEROSOL, METERED;INHALATION0.05MG/INHMOMETASONE FUROATE2014-04-25PrescriptionYes
200153NDAORGANON001LIPTRUZETTABLET;ORALEQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ATORVASTATIN CALCIUM; EZETIMIBE2013-05-03DiscontinuedNo
002LIPTRUZETTABLET;ORALEQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ATORVASTATIN CALCIUM; EZETIMIBE2013-05-03DiscontinuedNo
003LIPTRUZETTABLET;ORALEQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ATORVASTATIN CALCIUM; EZETIMIBE2013-05-03DiscontinuedNo
004LIPTRUZETTABLET;ORALEQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ATORVASTATIN CALCIUM; EZETIMIBE2013-05-03DiscontinuedNo
022518NDAORGANON LLC001DULERAAEROSOL, METERED;INHALATION0.005MG/INH;0.1MG/INHFORMOTEROL FUMARATE; MOMETASONE FUROATE2010-06-22PrescriptionYes
002DULERAAEROSOL, METERED;INHALATION0.005MG/INH;0.2MG/INHFORMOTEROL FUMARATE; MOMETASONE FUROATE2010-06-22PrescriptionYes
003DULERAAEROSOL, METERED;INHALATION0.005MG/INH;0.05MG/INHFORMOTEROL FUMARATE; MOMETASONE FUROATE2010-06-22PrescriptionYes
021529NDAORGANON001IMPLANONIMPLANT;IMPLANTATION68MG/IMPLANTETONOGESTREL2006-07-17DiscontinuedNo
002NEXPLANONIMPLANT;IMPLANTATION68MG/IMPLANTETONOGESTREL2006-07-17PrescriptionYes
021313NDAORGANON LLC001CLARINEX-D 12 HOURTABLET, EXTENDED RELEASE;ORAL2.5MG;120MGDESLORATADINE; PSEUDOEPHEDRINE SULFATE2006-02-01PrescriptionYes
021273BLAORGANON USA INC001FOLLISTIM AQINJECTABLE;SUBCUTANEOUS75 IU/0.5MLFOLLITROPIN ALFA/BETA2005-08-26DiscontinuedNo
002FOLLISTIM AQINJECTABLE;SUBCUTANEOUS150 IU/0.5MLFOLLITROPIN ALFA/BETA2005-08-26DiscontinuedNo
021762NDAORGANON LLC001FOSAMAX PLUS DTABLET;ORALEQ 70MG BASE;2,800 IUALENDRONATE SODIUM; CHOLECALCIFEROL2005-04-07PrescriptionNo
002FOSAMAX PLUS DTABLET;ORALEQ 70MG BASE;5,600 IUALENDRONATE SODIUM; CHOLECALCIFEROL2005-04-07PrescriptionYes
021067NDAORGANON LLC001ASMANEX TWISTHALERPOWDER;INHALATION0.22MG/INHMOMETASONE FUROATE2005-03-30PrescriptionYes
002ASMANEX TWISTHALERPOWDER;INHALATION0.11MG/INHMOMETASONE FUROATE2005-03-30PrescriptionNo
021605NDAORGANON001CLARINEX D 24 HOURTABLET, EXTENDED RELEASE;ORAL5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DESLORATADINE; PSEUDOEPHEDRINE SULFATE2005-03-03DiscontinuedNo
021687NDAORGANON001VYTORINTABLET;ORAL10MG;10MGEZETIMIBE; SIMVASTATIN2004-07-23PrescriptionNo
002VYTORINTABLET;ORAL10MG;20MGEZETIMIBE; SIMVASTATIN2004-07-23PrescriptionNo
003VYTORINTABLET;ORAL10MG;40MGEZETIMIBE; SIMVASTATIN2004-07-23PrescriptionNo
004VYTORINTABLET;ORAL10MG;80MGEZETIMIBE; SIMVASTATIN2004-07-23PrescriptionYes
021211BLAORGANON USA LLC001FOLLISTIM AQINJECTABLE;SUBCUTANEOUS300 IU/0.36MLFOLLITROPIN ALFA/BETA2004-03-23PrescriptionNo
002FOLLISTIM AQINJECTABLE;SUBCUTANEOUS600 IU/0.72MLFOLLITROPIN ALFA/BETA2004-03-23PrescriptionNo
003FOLLISTIM AQINJECTABLE;SUBCUTANEOUS150 IU/0.18MLFOLLITROPIN ALFA/BETA2004-03-23DiscontinuedNo
004FOLLISTIM AQINJECTABLE;SUBCUTANEOUS900 IU/1.08MLFOLLITROPIN ALFA/BETA2004-03-23PrescriptionNo
021445NDAORGANON001ZETIATABLET;ORAL10MGEZETIMIBE2002-10-25PrescriptionYes
021409NDAORGANON001SINGULAIRGRANULE;ORALEQ 4MG BASE/PACKETMONTELUKAST SODIUM2002-07-26PrescriptionYes
021312NDAORGANON001CLARINEXTABLET, ORALLY DISINTEGRATING;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DESLORATADINE2002-06-26DiscontinuedNo
002CLARINEXTABLET, ORALLY DISINTEGRATING;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**DESLORATADINE2002-06-26DiscontinuedNo
021165NDAORGANON001CLARINEXTABLET;ORAL5MGDESLORATADINE2001-12-21PrescriptionYes
021187NDAORGANON USA ORGANON001NUVARINGRING;VAGINAL0.015MG/24HR;0.12MG/24HRETHINYL ESTRADIOL; ETONOGESTREL2001-10-03PrescriptionYes
021208NDAORGANON USA ORGANON001REMERON SOLTABTABLET, ORALLY DISINTEGRATING;ORAL15MGMIRTAZAPINE2001-01-12PrescriptionYes
002REMERON SOLTABTABLET, ORALLY DISINTEGRATING;ORAL30MGMIRTAZAPINE2001-01-12PrescriptionNo
003REMERON SOLTABTABLET, ORALLY DISINTEGRATING;ORAL45MGMIRTAZAPINE2001-01-12PrescriptionNo
020984NDAORGANON USA INC001RAPLONINJECTABLE;INJECTION100MG/VIALRAPACURONIUM BROMIDE1999-08-18DiscontinuedNo
002RAPLONINJECTABLE;INJECTION200MG/VIALRAPACURONIUM BROMIDE1999-08-18DiscontinuedNo
021057NDAORGANON USA ORGANON001GANIRELIX ACETATEINJECTABLE;INJECTION250MCG/0.5MLGANIRELIX ACETATE1999-07-29PrescriptionYes
020865NDAORGANON001MAXALT-MLTTABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**RIZATRIPTAN BENZOATE1998-06-29DiscontinuedNo
002MAXALT-MLTTABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASERIZATRIPTAN BENZOATE1998-06-29PrescriptionYes
020864NDAORGANON LLC001MAXALTTABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**RIZATRIPTAN BENZOATE1998-06-29DiscontinuedNo
002MAXALTTABLET;ORALEQ 10MG BASERIZATRIPTAN BENZOATE1998-06-29PrescriptionYes
020829NDAORGANON002SINGULAIRTABLET;ORALEQ 10MG BASEMONTELUKAST SODIUM1998-02-20PrescriptionYes
020830NDAORGANON001SINGULAIRTABLET, CHEWABLE;ORALEQ 5MG BASEMONTELUKAST SODIUM1998-02-20PrescriptionYes
002SINGULAIRTABLET, CHEWABLE;ORALEQ 4MG BASEMONTELUKAST SODIUM1998-02-20PrescriptionNo
020788NDAORGANON001PROPECIATABLET;ORAL1MGFINASTERIDE1997-12-19PrescriptionYes
020762NDAORGANON LLC001NASONEXSPRAY, METERED;NASAL0.05MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MOMETASONE FUROATE1997-10-01DiscontinuedNo
020582BLAORGANON USA INC001FOLLISTIMINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS75 IU/VIALFOLLITROPIN ALFA/BETA1997-09-29DiscontinuedNo
002FOLLISTIMINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS150 IU/VIALFOLLITROPIN ALFA/BETA1997-09-29DiscontinuedNo
020580BLAORGANON USA INC001COTAZYMCAPSULE;ORAL30,000USP UNITS;8,000USP UNITS;30,000USP UNITSPANCRELIPASE (AMYLASE;LIPASE;PROTEASE)1996-12-09DiscontinuedNo
020415NDAORGANON001REMERONTABLET;ORAL15MGMIRTAZAPINE1996-06-14PrescriptionYes
002REMERONTABLET;ORAL30MGMIRTAZAPINE1996-06-14PrescriptionNo
003REMERONTABLET;ORAL45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MIRTAZAPINE1996-06-14DiscontinuedNo
020560NDAORGANON001FOSAMAXTABLET;ORALEQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALENDRONATE SODIUM1995-09-29DiscontinuedNo
002FOSAMAXTABLET;ORALEQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALENDRONATE SODIUM1995-09-29DiscontinuedNo
003FOSAMAXTABLET;ORALEQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALENDRONATE SODIUM1995-09-29DiscontinuedNo
004FOSAMAXTABLET;ORALEQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALENDRONATE SODIUM1995-09-29DiscontinuedNo
005FOSAMAXTABLET;ORALEQ 70MG BASEALENDRONATE SODIUM1995-09-29PrescriptionYes
020387NDAORGANON001HYZAARTABLET;ORAL12.5MG;50MGHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM1995-04-28PrescriptionNo
002HYZAARTABLET;ORAL25MG;100MGHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM1995-04-28PrescriptionNo
003HYZAARTABLET;ORAL12.5MG;100MGHYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM1995-04-28PrescriptionNo
020386NDAORGANON001COZAARTABLET;ORAL25MGLOSARTAN POTASSIUM1995-04-14PrescriptionNo
002COZAARTABLET;ORAL50MGLOSARTAN POTASSIUM1995-04-14PrescriptionNo
003COZAARTABLET;ORAL100MGLOSARTAN POTASSIUM1995-04-14PrescriptionYes
020328BLAORGANON USA INC001HUMEGONINJECTABLE;INJECTION75 IU/VIAL;75 IU/VIALMENOTROPINS (FSH;LH)1994-09-01DiscontinuedNo
002HUMEGONINJECTABLE;INJECTION150 IU/VIAL;150 IU/VIALMENOTROPINS (FSH;LH)1994-09-01DiscontinuedNo
020214NDAORGANON USA INC001ZEMURONINJECTABLE;INJECTION50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ROCURONIUM BROMIDE1994-03-17DiscontinuedNo
002ZEMURONINJECTABLE;INJECTION10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ROCURONIUM BROMIDE1994-03-17DiscontinuedNo
003ZEMURONINJECTABLE;INJECTION100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ROCURONIUM BROMIDE1994-03-17DiscontinuedNo
020071NDAORGANON USA INC001DESOGENTABLET;ORAL-210.15MG;0.03MGDESOGESTREL; ETHINYL ESTRADIOL1992-12-10DiscontinuedNo
002DESOGENTABLET;ORAL-280.15MG;0.03MGDESOGESTREL; ETHINYL ESTRADIOL1992-12-10DiscontinuedNo
020180NDAORGANON001PROSCARTABLET;ORAL5MGFINASTERIDE1992-06-19PrescriptionYes
019766NDAORGANON001ZOCORTABLET;ORAL5MGSIMVASTATIN1991-12-23PrescriptionNo
002ZOCORTABLET;ORAL10MGSIMVASTATIN1991-12-23PrescriptionNo
003ZOCORTABLET;ORAL20MGSIMVASTATIN1991-12-23PrescriptionNo
004ZOCORTABLET;ORAL40MGSIMVASTATIN1991-12-23PrescriptionNo
005ZOCORTABLET;ORAL80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SIMVASTATIN1991-12-23DiscontinuedNo
019856NDAORGANON LLC001SINEMET CRTABLET, EXTENDED RELEASE;ORAL50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CARBIDOPA; LEVODOPA1991-05-30DiscontinuedNo
002SINEMET CRTABLET, EXTENDED RELEASE;ORAL25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CARBIDOPA; LEVODOPA1991-05-30DiscontinuedNo
019638NDAORGANON USA INC001ARDUANINJECTABLE;INJECTION10MG/VIALPIPECURONIUM BROMIDE1990-06-26DiscontinuedNo
019796NDAORGANON001ELOCONLOTION;TOPICAL0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MOMETASONE FUROATE1989-03-30DiscontinuedNo
019716NDAORGANON001DIPROLENELOTION, AUGMENTED;TOPICALEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BETAMETHASONE DIPROPIONATE1988-08-01DiscontinuedNo
089624ANDAORGANON USA INC001REVERSOLINJECTABLE;INJECTION10MG/MLEDROPHONIUM CHLORIDE1988-05-13DiscontinuedNo
019625NDAORGANON001ELOCONCREAM;TOPICAL0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MOMETASONE FUROATE1987-05-06DiscontinuedNo
002ELOCONCREAM;TOPICAL0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MOMETASONE FUROATE1987-05-06DiscontinuedNo
019543NDAORGANON001ELOCONOINTMENT;TOPICAL0.1%MOMETASONE FUROATE1987-04-30DiscontinuedNo
019555NDAORGANON001DIPROLENE AFCREAM, AUGMENTED;TOPICALEQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BETAMETHASONE DIPROPIONATE1987-04-27DiscontinuedNo
018827NDAORGANON001LOTRISONECREAM;TOPICALEQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE1984-07-10DiscontinuedNo
018776NDAORGANON USA INC002NORCURONINJECTABLE;INJECTION10MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VECURONIUM BROMIDE1984-04-30DiscontinuedNo
003NORCURONINJECTABLE;INJECTION20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VECURONIUM BROMIDE1984-04-30DiscontinuedNo
018741NDAORGANON001DIPROLENEOINTMENT, AUGMENTED;TOPICALEQ 0.05% BASEBETAMETHASONE DIPROPIONATE1983-07-27PrescriptionYes
086750ANDAORGANON USA INC001WIGRETTESTABLET;SUBLINGUAL2MGERGOTAMINE TARTRATE1982-07-29DiscontinuedNo
087535ANDAORGANON USA INC001METHYLPREDNISOLONEINJECTABLE;INJECTIONEQ 500MG BASE/VIALMETHYLPREDNISOLONE SODIUM SUCCINATE1982-06-25DiscontinuedNo
002METHYLPREDNISOLONEINJECTABLE;INJECTIONEQ 1GM BASE/VIALMETHYLPREDNISOLONE SODIUM SUCCINATE1982-06-25DiscontinuedNo
086562ANDAORGANON USA INC001WIGRAINETABLET;ORAL100MG;1MGCAFFEINE; ERGOTAMINE TARTRATE1980-11-05DiscontinuedNo
018312NDAORGANON USA INC001CALDEROLCAPSULE;ORAL0.02MGCALCIFEDIOL1980-08-05DiscontinuedNo
002CALDEROLCAPSULE;ORAL0.05MGCALCIFEDIOL1980-08-05DiscontinuedNo
087014ANDAORGANON USA INC001ORGATRAXINJECTABLE;INJECTION25MG/MLHYDROXYZINE HYDROCHLORIDE1980-06-27DiscontinuedNo
002ORGATRAXINJECTABLE;INJECTION50MG/MLHYDROXYZINE HYDROCHLORIDE1980-06-27DiscontinuedNo
017692BLAORGANON USA LLC001PREGNYLINJECTABLE;INJECTION10,000 UNITS/VIALGONADOTROPIN, CHORIONIC1976-10-20PrescriptionNo
017555NDAORGANON001SINEMETTABLET;ORAL10MG;100MGCARBIDOPA; LEVODOPA1975-05-02PrescriptionNo
002SINEMETTABLET;ORAL25MG;250MGCARBIDOPA; LEVODOPA1975-05-02PrescriptionNo
003SINEMETTABLET;ORAL25MG;100MGCARBIDOPA; LEVODOPA1975-05-02PrescriptionNo
017015NDAORGANON USA INC001PAVULONINJECTABLE;INJECTION2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**PANCURONIUM BROMIDE1972-10-24DiscontinuedNo
002PAVULONINJECTABLE;INJECTION1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**PANCURONIUM BROMIDE1972-10-24DiscontinuedNo
080997ANDAORGANON USA INC001SUCCINYLCHOLINE CHLORIDEINJECTABLE;INJECTION20MG/MLSUCCINYLCHOLINE CHLORIDE1972-09-20DiscontinuedNo
014602NDAORGANON001CELESTONE SOLUSPANINJECTABLE;INJECTION3MG/ML;EQ 3MG BASE/MLBETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE1965-03-03PrescriptionYes
014006NDAORGANON USA INC002MAXIBOLINELIXIR;ORAL2MG/5MLETHYLESTRENOL1965-01-07DiscontinuedNo
014005NDAORGANON USA INC002MAXIBOLINTABLET;ORAL2MGETHYLESTRENOL1964-05-28DiscontinuedNo
011891NDAORGANON USA INC001DURABOLININJECTABLE;INJECTION25MG/MLNANDROLONE PHENPROPIONATE1959-10-30DiscontinuedNo
002DURABOLININJECTABLE;INJECTION50MG/MLNANDROLONE PHENPROPIONATE1959-10-30DiscontinuedNo
011228NDAORGANON USA INC001LIQUAMARTABLET;ORAL3MGPHENPROCOUMON1957-12-30DiscontinuedNo
005490NDAORGANON USA INC002LYNORALTABLET;ORAL0.05MGETHINYL ESTRADIOL1944-04-13DiscontinuedNo
003LYNORALTABLET;ORAL0.01MGETHINYL ESTRADIOL1944-04-13DiscontinuedNo
001104NDAORGANON USA INC001DOCAINJECTABLE;INJECTION5MG/MLDESOXYCORTICOSTERONE ACETATE1939-08-17DiscontinuedNo