FDA.reportPublic FDA data

Application 020838

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATACANDCANDESARTAN CILEXETILTABLET;ORAL4MGYesNo
002ATACANDCANDESARTAN CILEXETILTABLET;ORAL8MGYesNo
003ATACANDCANDESARTAN CILEXETILTABLET;ORAL16MGYesNo
004ATACANDCANDESARTAN CILEXETILTABLET;ORAL32MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0186-0004ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0008ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0016ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
0186-0032ATACANDCandesartan cilexetilAstraZeneca Pharmaceuticals LPNDACurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-658Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-659Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-660Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
49884-661Candesartan cilexetilCandesartan cilexetilPar Pharmaceutical Inc.NDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-119Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-130Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
60687-241Candesartan cilexetilCandesartan cilexetilAmerican Health PackagingNDA AUTHORIZED GENERICCurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-640ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-641ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-642ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
62559-643ATACANDCandesartan CilexetilANI Pharmaceuticals, Inc.NDACurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2126Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2127Candesartan cilexetilCandesartan cilexetilBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-3376ATACANDCandesartan cilexetilBryant Ranch PrepackNDACurrent
63629-3376ATACANDCandesartan cilexetilBryant Ranch PrepackNDACurrent
68151-4145ATACANDCandesartan cilexetilCarilion Materials ManagementNDACurrent
68151-4146ATACANDCandesartan cilexetilCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63699SUPPL2020-06-25
63695SUPPL2020-06-25
13577SUPPL2016-02-11
3529SUPPL2016-02-11
26017SUPPL2015-02-10
13576SUPPL2015-02-09
26018SUPPL2013-04-30
35485SUPPL2013-04-29
3528SUPPL2012-05-02
35484SUPPL2012-05-01
13575SUPPL2012-04-17
3527SUPPL2012-04-16
44075ORIG2011-12-22
26016SUPPL2011-07-05
35483SUPPL2011-06-28
26015SUPPL2009-11-05
35482SUPPL2009-10-23
51279SUPPL2007-01-30
35481SUPPL2006-08-21
3526SUPPL2006-08-21
13573SUPPL2005-05-20
3524SUPPL2005-05-20
51278SUPPL2005-03-15
26014SUPPL2005-02-23
13574SUPPL2005-02-23
3525SUPPL2004-12-30
51277SUPPL2004-08-27
41744SUPPL2004-05-27
26013SUPPL2004-05-27
21001SUPPL2004-05-27
51275SUPPL2003-11-02
3523SUPPL2003-05-29
21000ORIG2003-05-22
51276SUPPL2003-01-08
35480SUPPL2002-09-13
26012SUPPL2002-09-13
51274SUPPL1999-03-15
35479ORIG1998-06-04
26011ORIG1998-06-04
63880ORIG1900-01-01
63879ORIG1900-01-01
63878ORIG1900-01-01
63877ORIG1900-01-01
63876ORIG1900-01-01
63875ORIG1900-01-01
54099ORIG1900-01-01
54098ORIG1900-01-01
54097ORIG1900-01-01