FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
761359BLATAKEDA PHARMS USA001ENTYVIOINJECTABLE;INTRAVENOUS300MGVEDOLIZUMAB2024-04-18PrescriptionNo
002ENTYVIOINJECTABLE;SUBCUTANEOUS108MG/0.68MLVEDOLIZUMAB2024-04-18PrescriptionNo
213976NDATAKEDA PHARMS USA001EOHILIASUSPENSION;ORAL2MG/10MLBUDESONIDE2024-02-09PrescriptionYes
217564NDATAKEDA PHARMS USA001FRUZAQLACAPSULE;ORAL1MGFRUQUINTINIB2023-11-08PrescriptionNo
002FRUZAQLACAPSULE;ORAL5MGFRUQUINTINIB2023-11-08PrescriptionYes
761133BLATAKEDA PHARMS USA001ENTYVIOINJECTABLE;INTRAVENOUS300MGVEDOLIZUMAB2023-09-27PrescriptionNo
002ENTYVIOINJECTABLE;INJECTION108MG/0.68MLVEDOLIZUMAB2023-09-27PrescriptionNo
215596NDATAKEDA PHARMS USA001LIVTENCITYTABLET;ORAL200MGMARIBAVIR2021-11-23PrescriptionYes
215310NDATAKEDA PHARMS USA001EXKIVITYCAPSULE;ORALEQ 40MG BASEMOBOCERTINIB SUCCINATE2021-09-15DiscontinuedNo
210166NDATAKEDA PHARMS USA001MOTEGRITYTABLET;ORALEQ 1MG BASEPRUCALOPRIDE SUCCINATE2018-12-14PrescriptionNo
002MOTEGRITYTABLET;ORALEQ 2MG BASEPRUCALOPRIDE SUCCINATE2018-12-14PrescriptionYes
022063NDATAKEDA PHARMS USA001MYDAYISCAPSULE, EXTENDED RELEASE;ORAL3.125MG;3.125MG;3.125MG;3.125MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2017-06-20PrescriptionNo
002MYDAYISCAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2017-06-20PrescriptionNo
003MYDAYISCAPSULE, EXTENDED RELEASE;ORAL9.375MG;9.375MG;9.375MG;9.375MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2017-06-20PrescriptionNo
004MYDAYISCAPSULE, EXTENDED RELEASE;ORAL12.5MG;12.5MG;12.5MG;12.5MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2017-06-20PrescriptionYes
208772NDATAKEDA PHARMS USA001ALUNBRIGTABLET;ORAL30MGBRIGATINIB2017-04-28PrescriptionNo
002ALUNBRIGTABLET;ORAL90MGBRIGATINIB2017-04-28PrescriptionNo
003ALUNBRIGTABLET;ORAL180MGBRIGATINIB2017-04-28PrescriptionYes
208510NDATAKEDA PHARMS USA001VYVANSETABLET, CHEWABLE;ORAL10MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionNo
002VYVANSETABLET, CHEWABLE;ORAL20MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionNo
003VYVANSETABLET, CHEWABLE;ORAL30MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionNo
004VYVANSETABLET, CHEWABLE;ORAL40MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionNo
005VYVANSETABLET, CHEWABLE;ORAL50MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionNo
006VYVANSETABLET, CHEWABLE;ORAL60MGLISDEXAMFETAMINE DIMESYLATE2017-01-28PrescriptionYes
208056NDATAKEDA PHARMS USA001DEXILANT SOLUTABTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MGDEXLANSOPRAZOLE2016-01-26DiscontinuedNo
208462NDATAKEDA PHARMS USA001NINLAROCAPSULE;ORALEQ 2.3MG BASEIXAZOMIB CITRATE2015-11-20PrescriptionNo
002NINLAROCAPSULE;ORALEQ 3MG BASEIXAZOMIB CITRATE2015-11-20PrescriptionNo
003NINLAROCAPSULE;ORALEQ 4MG BASEIXAZOMIB CITRATE2015-11-20PrescriptionYes
204734NDATAKEDA PHARMS USA001FOSRENOLPOWDER;ORALEQ 750MG BASELANTHANUM CARBONATE2014-09-24PrescriptionNo
002FOSRENOLPOWDER;ORALEQ 1GM BASELANTHANUM CARBONATE2014-09-24PrescriptionYes
125476BLATAKEDA PHARMS USA001ENTYVIOINJECTABLE;INJECTION300MGVEDOLIZUMAB2014-05-20PrescriptionNo
204447NDATAKEDA PHARMS USA001TRINTELLIXTABLET;ORALEQ 5MG BASEVORTIOXETINE HYDROBROMIDE2013-09-30PrescriptionNo
002TRINTELLIXTABLET;ORALEQ 10MG BASEVORTIOXETINE HYDROBROMIDE2013-09-30PrescriptionNo
003TRINTELLIXTABLET;ORALEQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**VORTIOXETINE HYDROBROMIDE2013-09-30DiscontinuedNo
004TRINTELLIXTABLET;ORALEQ 20MG BASEVORTIOXETINE HYDROBROMIDE2013-09-30PrescriptionYes
203414NDATAKEDA PHARMS USA001KAZANOTABLET;ORALEQ 12.5MG BASE;500MGALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE2013-01-25PrescriptionNo
002KAZANOTABLET;ORALEQ 12.5MG BASE;1GMALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE2013-01-25PrescriptionYes
022271NDATAKEDA PHARMS USA001NESINATABLET;ORALEQ 6.25MG BASEALOGLIPTIN BENZOATE2013-01-25PrescriptionNo
002NESINATABLET;ORALEQ 12.5MG BASEALOGLIPTIN BENZOATE2013-01-25PrescriptionNo
003NESINATABLET;ORALEQ 25MG BASEALOGLIPTIN BENZOATE2013-01-25PrescriptionYes
022426NDATAKEDA PHARMS USA001OSENITABLET;ORALEQ 25MG BASE;EQ 15MG BASEALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25PrescriptionNo
002OSENITABLET;ORALEQ 25MG BASE;EQ 30MG BASEALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25PrescriptionNo
003OSENITABLET;ORALEQ 25MG BASE;EQ 45MG BASEALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25PrescriptionYes
004OSENITABLET;ORALEQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25DiscontinuedNo
005OSENITABLET;ORALEQ 12.5MG BASE;EQ 30MG BASEALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25PrescriptionNo
006OSENITABLET;ORALEQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE2013-01-25DiscontinuedNo
203441NDATAKEDA PHARMS USA001GATTEX KITPOWDER;SUBCUTANEOUS5MG/VIALTEDUGLUTIDE2012-12-21PrescriptionYes
203469NDATAKEDA PHARMS USA001ICLUSIGTABLET;ORALEQ 15MG BASEPONATINIB HYDROCHLORIDE2012-12-14PrescriptionNo
002ICLUSIGTABLET;ORALEQ 45MG BASEPONATINIB HYDROCHLORIDE2012-12-14PrescriptionYes
003ICLUSIGTABLET;ORALEQ 30MG BASEPONATINIB HYDROCHLORIDE2012-12-14PrescriptionNo
004ICLUSIGTABLET;ORALEQ 10MG BASEPONATINIB HYDROCHLORIDE2012-12-14PrescriptionNo
202799NDATAKEDA PHARMS USA007OMONTYSSOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 10MG BASE/ML (EQ 10MG BASE/ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
008OMONTYSSOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 20MG BASE/2ML (EQ 10MG BASE/ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
001OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
002OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
003OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
004OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
005OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
006OMONTYS PRESERVATIVE FREESOLUTION;INTRAVENOUS, SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)PEGINESATIDE ACETATE2012-03-27DiscontinuedNo
022150NDATAKEDA PHARMS USA001FIRAZYRINJECTABLE;SUBCUTANEOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)ICATIBANT ACETATE2011-08-25PrescriptionYes
022037NDATAKEDA PHARMS USA001INTUNIVTABLET, EXTENDED RELEASE;ORALEQ 1MG BASEGUANFACINE HYDROCHLORIDE2009-09-02PrescriptionNo
002INTUNIVTABLET, EXTENDED RELEASE;ORALEQ 2MG BASEGUANFACINE HYDROCHLORIDE2009-09-02PrescriptionNo
003INTUNIVTABLET, EXTENDED RELEASE;ORALEQ 3MG BASEGUANFACINE HYDROCHLORIDE2009-09-02PrescriptionNo
004INTUNIVTABLET, EXTENDED RELEASE;ORALEQ 4MG BASEGUANFACINE HYDROCHLORIDE2009-09-02PrescriptionYes
022352NDATAKEDA PHARMS USA001COLCRYSTABLET;ORAL0.6MGCOLCHICINE2009-07-29DiscontinuedNo
022024NDATAKEDA PHARMS USA001ACTOPLUS MET XRTABLET, EXTENDED RELEASE;ORAL1GM;EQ 15MG BASEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE2009-05-12DiscontinuedNo
002ACTOPLUS MET XRTABLET, EXTENDED RELEASE;ORAL1GM;EQ 30MG BASEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE2009-05-12DiscontinuedNo
021856NDATAKEDA PHARMS USA001ULORICTABLET;ORAL40MGFEBUXOSTAT2009-02-13PrescriptionNo
002ULORICTABLET;ORAL80MGFEBUXOSTAT2009-02-13PrescriptionYes
022287NDATAKEDA PHARMS USA001DEXILANTCAPSULE, DELAYED RELEASE;ORAL30MGDEXLANSOPRAZOLE2009-01-30PrescriptionNo
002DEXILANTCAPSULE, DELAYED RELEASE;ORAL60MGDEXLANSOPRAZOLE2009-01-30PrescriptionYes
021977NDATAKEDA PHARMS USA001VYVANSECAPSULE;ORAL30MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
002VYVANSECAPSULE;ORAL50MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
003VYVANSECAPSULE;ORAL70MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionYes
004VYVANSECAPSULE;ORAL20MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
005VYVANSECAPSULE;ORAL40MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
006VYVANSECAPSULE;ORAL60MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
007VYVANSECAPSULE;ORAL10MGLISDEXAMFETAMINE DIMESYLATE2007-02-23PrescriptionNo
022000NDATAKEDA PHARMS USA001LIALDATABLET, DELAYED RELEASE;ORAL1.2GMMESALAMINE2007-01-16PrescriptionYes
021925NDATAKEDA PHARMS USA001DUETACTTABLET;ORAL2MG;30MGGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE2006-07-28PrescriptionYes
002DUETACTTABLET;ORAL4MG;30MGGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE2006-07-28PrescriptionNo
021842NDATAKEDA PHARMS USA001ACTOPLUS METTABLET;ORAL500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE2005-08-29DiscontinuedNo
002ACTOPLUS METTABLET;ORAL850MG;EQ 15MG BASEMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE2005-08-29PrescriptionYes
021782NDATAKEDA PHARMS USA001ROZEREMTABLET;ORAL8MGRAMELTEON2005-07-22PrescriptionYes
021468NDATAKEDA PHARMS USA001FOSRENOLTABLET, CHEWABLE;ORALEQ 250MG BASELANTHANUM CARBONATE2004-10-26DiscontinuedNo
002FOSRENOLTABLET, CHEWABLE;ORALEQ 500MG BASELANTHANUM CARBONATE2004-10-26PrescriptionNo
003FOSRENOLTABLET, CHEWABLE;ORALEQ 750MG BASELANTHANUM CARBONATE2004-10-26PrescriptionNo
004FOSRENOLTABLET, CHEWABLE;ORALEQ 1GM BASELANTHANUM CARBONATE2004-10-26PrescriptionYes
021602NDATAKEDA PHARMS USA001VELCADEINJECTABLE;INTRAVENOUS, SUBCUTANEOUS3.5MG/VIALBORTEZOMIB2003-05-13PrescriptionYes
021428NDATAKEDA PHARMS USA001PREVACIDTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MGLANSOPRAZOLE2002-08-30PrescriptionNo
002PREVACIDTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MGLANSOPRAZOLE2002-08-30PrescriptionYes
021303NDATAKEDA PHARMS USA001ADDERALL XR 10CAPSULE, EXTENDED RELEASE;ORAL2.5MG;2.5MG;2.5MG;2.5MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionNo
006ADDERALL XR 15CAPSULE, EXTENDED RELEASE;ORAL3.75MG;3.75MG;3.75MG;3.75MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionNo
002ADDERALL XR 20CAPSULE, EXTENDED RELEASE;ORAL5MG;5MG;5MG;5MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionNo
004ADDERALL XR 25CAPSULE, EXTENDED RELEASE;ORAL6.25MG;6.25MG;6.25MG;6.25MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionNo
003ADDERALL XR 30CAPSULE, EXTENDED RELEASE;ORAL7.5MG;7.5MG;7.5MG;7.5MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionYes
005ADDERALL XR 5CAPSULE, EXTENDED RELEASE;ORAL1.25MG;1.25MG;1.25MG;1.25MGAMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE2001-10-11PrescriptionNo
021073NDATAKEDA PHARMS USA001ACTOSTABLET;ORALEQ 15MG BASEPIOGLITAZONE HYDROCHLORIDE1999-07-15PrescriptionNo
002ACTOSTABLET;ORALEQ 30MG BASEPIOGLITAZONE HYDROCHLORIDE1999-07-15PrescriptionNo
003ACTOSTABLET;ORALEQ 45MG BASEPIOGLITAZONE HYDROCHLORIDE1999-07-15PrescriptionYes
050757NDATAKEDA PHARMS USA001PREVPAC (COPACKAGED)CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE1997-12-02DiscontinuedNo
020712NDATAKEDA PHARMS USA001CARBATROLCAPSULE, EXTENDED RELEASE;ORAL200MGCARBAMAZEPINE1997-09-30PrescriptionNo
002CARBATROLCAPSULE, EXTENDED RELEASE;ORAL300MGCARBAMAZEPINE1997-09-30PrescriptionYes
003CARBATROLCAPSULE, EXTENDED RELEASE;ORAL100MGCARBAMAZEPINE1997-09-30PrescriptionNo
020333NDATAKEDA PHARMS USA001AGRYLINCAPSULE;ORALEQ 0.5MG BASEANAGRELIDE HYDROCHLORIDE1997-03-14PrescriptionNo
002AGRYLINCAPSULE;ORALEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**ANAGRELIDE HYDROCHLORIDE1997-03-14DiscontinuedNo
019815NDATAKEDA PHARMS USA001PROAMATINETABLET;ORAL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MIDODRINE HYDROCHLORIDE1996-09-06DiscontinuedNo
002PROAMATINETABLET;ORAL5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MIDODRINE HYDROCHLORIDE1996-09-06DiscontinuedNo
003PROAMATINETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**MIDODRINE HYDROCHLORIDE1996-09-06DiscontinuedNo
020406NDATAKEDA PHARMS USA001PREVACIDCAPSULE, DELAYED REL PELLETS;ORAL15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**LANSOPRAZOLE1995-05-10DiscontinuedNo
002PREVACIDCAPSULE, DELAYED REL PELLETS;ORAL30MGLANSOPRAZOLE1995-05-10PrescriptionYes
020049NDATAKEDA PHARMS USA001PENTASACAPSULE, EXTENDED RELEASE;ORAL250MGMESALAMINE1993-05-10PrescriptionNo
002PENTASACAPSULE, EXTENDED RELEASE;ORAL500MGMESALAMINE1993-05-10PrescriptionYes
050601NDATAKEDA001CERADONINJECTABLE;INJECTIONEQ 1GM BASE/VIALCEFOTIAM HYDROCHLORIDE1988-12-30DiscontinuedNo