candesartan Oral Tablet

Brand(s)
Atacand
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Lp (2015-02-06)
Oldest Current Product
1998-09-14
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\CANDESARTAN
FDAOB
ORAL\TABLET\CANDESARTAN CILEXETIL
SPL Active
ORAL\TABLET\CANDESARTAN CILEXETIL
SPL Moiety
ORAL\TABLET\CANDESARTAN

product(s) by strength(s)

candesartan cilexetil 16 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860016AtacandNDAAstrazeneca Lp1998-09-14CANDESARTAN CILEXETILORALTABLETNDA020838a73e1339-9643-4eea-2cbe-e879c88fb50e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815938ANDASandoz Inc2013-05-21CANDESARTAN CILEXETILORALTABLETANDA0787026498c72c-51cf-4f7d-9a87-2f3c2a3bc95b
2498840660NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2013-05-21CANDESARTAN CILEXETILORALTABLETNDA0208381c90aa68-cc12-41ef-aebc-2616ae45683a
3605053620ANDAApotex Corp2014-01-13CANDESARTAN CILEXETILORALTABLETANDA202079be36901a-b2fe-5834-755b-9a44e6748890

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684413AtacandNDAPhysicians Total Care, Inc.2000-11-21CANDESARTAN CILEXETILORALTABLET001860016NDA02083807b7d9af-75db-4593-817a-a2543145233c
2551549610AtacandNDACardinal Health2009-11-11CANDESARTAN CILEXETILORALTABLET001860016NDA020838f61ff26d-a310-43cc-981a-da02e3d786a9
3636293376AtacandNDABryant Ranch Prepack1998-09-14CANDESARTAN CILEXETILORALTABLET001860016NDA020838c4102f20-07fc-47ec-9c02-51b9578fbedf
4680840877ANDAAmerican Health Packaging2015-09-01CANDESARTAN CILEXETILORALTABLET007815938ANDA0787020466fd6b-9270-489a-9f6a-70ef9abe9285
5681513838ANDACarilion Materials Management2013-05-21CANDESARTAN CILEXETILORALTABLET007815938ANDA078702a67f4f53-76c7-4239-9dd6-fef8e8019e9a

candesartan cilexetil 32 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860032AtacandNDAAstrazeneca Lp1998-09-14CANDESARTAN CILEXETILORALTABLETNDA020838a73e1339-9643-4eea-2cbe-e879c88fb50e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815939ANDASandoz Inc2013-05-21CANDESARTAN CILEXETILORALTABLETANDA0787026498c72c-51cf-4f7d-9a87-2f3c2a3bc95b
2498840661NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2013-05-21CANDESARTAN CILEXETILORALTABLETNDA0208381c90aa68-cc12-41ef-aebc-2616ae45683a
3605053621ANDAApotex Corp2014-01-13CANDESARTAN CILEXETILORALTABLETANDA202079be36901a-b2fe-5834-755b-9a44e6748890

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684612AtacandNDAPhysicians Total Care, Inc.2002-04-172013-06-30CANDESARTAN CILEXETILORALTABLET001860032NDA02083807b7d9af-75db-4593-817a-a2543145233c
2606870130NDA AUTHORIZED GENERICAmerican Health Packaging2015-09-01CANDESARTAN CILEXETILORALTABLET498840661NDA0208388d9a7eb7-fe06-4fd4-b6f2-1dd88d91838d

candesartan cilexetil 4 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860004AtacandNDAAstrazeneca Lp1998-09-14CANDESARTAN CILEXETILORALTABLETNDA020838a73e1339-9643-4eea-2cbe-e879c88fb50e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815936ANDASandoz Inc2013-05-21CANDESARTAN CILEXETILORALTABLETANDA0787026498c72c-51cf-4f7d-9a87-2f3c2a3bc95b
2498840658NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2013-05-21CANDESARTAN CILEXETILORALTABLETNDA0208381c90aa68-cc12-41ef-aebc-2616ae45683a
3605053618ANDAApotex Corp2014-01-13CANDESARTAN CILEXETILORALTABLETANDA202079be36901a-b2fe-5834-755b-9a44e6748890

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685591AtacandNDAPhysicians Total Care, Inc.2006-05-162011-06-30CANDESARTAN CILEXETILORALTABLET001860004NDA02083807b7d9af-75db-4593-817a-a2543145233c
2636294462AtacandNDABryant Ranch Prepack1998-09-14CANDESARTAN CILEXETILORALTABLET001860004NDA02083844634e6c-e1ea-4309-b44a-f6a1931fc688
3681514145AtacandNDACarilion Materials Management1998-09-14CANDESARTAN CILEXETILORALTABLET001860004NDA020838d0c94743-cb17-4581-962e-7add11ae52e7

candesartan cilexetil 8 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001860008AtacandNDAAstrazeneca Lp1998-09-14CANDESARTAN CILEXETILORALTABLETNDA020838a73e1339-9643-4eea-2cbe-e879c88fb50e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007815937ANDASandoz Inc2013-05-21CANDESARTAN CILEXETILORALTABLETANDA0787026498c72c-51cf-4f7d-9a87-2f3c2a3bc95b
2498840659NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2013-05-21CANDESARTAN CILEXETILORALTABLETNDA0208381c90aa68-cc12-41ef-aebc-2616ae45683a
3605053619ANDAApotex Corp2014-01-13CANDESARTAN CILEXETILORALTABLETANDA202079be36901a-b2fe-5834-755b-9a44e6748890

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685489AtacandNDAPhysicians Total Care, Inc.2006-05-012011-06-30CANDESARTAN CILEXETILORALTABLET001860008NDA02083807b7d9af-75db-4593-817a-a2543145233c
2606870119NDA AUTHORIZED GENERICAmerican Health Packaging2015-09-01CANDESARTAN CILEXETILORALTABLET498840659NDA0208388d9a7eb7-fe06-4fd4-b6f2-1dd88d91838d
3681514146AtacandNDACarilion Materials Management1998-09-14CANDESARTAN CILEXETILORALTABLET001860008NDA020838fd676896-5f5b-48da-becc-3736a6fc1f14

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078702CANDESARTAN CILEXETILSANDOZ INC2013-05-03ANDA078702_001, ANDA078702_002, ANDA078702_003, ANDA078702_004
2ANDA202079CANDESARTAN CILEXETILAPOTEX INC2014-01-10ANDA202079_001, ANDA202079_002, ANDA202079_003, ANDA202079_004
3NDA020838ATACANDASTRAZENECA PHARMACEUTICALS LP1998-06-04NDA020838_001, NDA020838_002, NDA020838_003, NDA020838_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078702_001RXCANDESARTAN CILEXETIL (4MG)ORALTABLETFalseAB2013-05-03CANDESARTAN CILEXETIL
2ANDA078702_002RXCANDESARTAN CILEXETIL (8MG)ORALTABLETFalseAB2013-05-03CANDESARTAN CILEXETIL
3ANDA078702_003RXCANDESARTAN CILEXETIL (16MG)ORALTABLETFalseAB2013-05-03CANDESARTAN CILEXETIL
4ANDA078702_004RXCANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2013-05-03CANDESARTAN CILEXETIL
5ANDA202079_001RXCANDESARTAN CILEXETIL (4MG)ORALTABLETFalseAB2014-01-10CANDESARTAN CILEXETIL
6ANDA202079_002RXCANDESARTAN CILEXETIL (8MG)ORALTABLETFalseAB2014-01-10CANDESARTAN CILEXETIL
7ANDA202079_003RXCANDESARTAN CILEXETIL (16MG)ORALTABLETFalseAB2014-01-10CANDESARTAN CILEXETIL
8ANDA202079_004RXCANDESARTAN CILEXETIL (32MG)ORALTABLETFalseAB2014-01-10CANDESARTAN CILEXETIL
9NDA020838_001RXCANDESARTAN CILEXETIL (4MG)ORALTABLETFalseAB1998-06-04ATACAND
10NDA020838_002RXCANDESARTAN CILEXETIL (8MG)ORALTABLETFalseAB1998-06-04ATACAND
11NDA020838_003RXCANDESARTAN CILEXETIL (16MG)ORALTABLETFalseAB1998-06-04ATACAND
12NDA020838_004RXCANDESARTAN CILEXETIL (32MG)ORALTABLETTrueAB1998-06-04ATACAND

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10466fd6b-9270-489a-9f6a-70ef9abe9285 (view SPL)These highlights do not include all the information needed to use candesartan cilexetil tablets safely and effectively. See full prescribing information for candesartan cilexetil tablets. Candesartan Cilexetil Tablets, for oral useINITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-131680840877
207b7d9af-75db-4593-817a-a2543145233c (view SPL)These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-08-123548684413, 548684612, 548685489, 548685591
31c90aa68-cc12-41ef-aebc-2616ae45683a (view SPL)These highlights do not include all the information needed to use candesartan cilexetil safely and effectively. See full prescribing information for candesartan cilexetil . Candesartan cilexetil Tablets Initial U.S. Approval: 1998prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2015-02-064498840658, 498840659, 498840660, 498840661
444634e6c-e1ea-4309-b44a-f6a1931fc688 (view SPL)These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636294462
56498c72c-51cf-4f7d-9a87-2f3c2a3bc95b (view SPL)These highlights do not include all the information needed to use candesartan cilexetil tablets safely and effectively. See full prescribing information for candesartan cilexetil tablets. Candesartan Cilexetil Tablets, for oral useINITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionSandoz Inc2013-05-062007815936, 007815937, 007815938, 007815939
68d9a7eb7-fe06-4fd4-b6f2-1dd88d91838d (view SPL)These highlights do not include all the information needed to use candesartan cilexetil safely and effectively. See full prescribing information for candesartan cilexetil . Candesartan Cilexetil TabletsInitial U.S. Approval: 1998prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-08-111606870119, 606870130
7a67f4f53-76c7-4239-9dd6-fef8e8019e9a (view SPL)These highlights do not include all the information needed to use candesartan cilexetil tablets safely and effectively. See full prescribing information for candesartan cilexetil tablets. Candesartan Cilexetil Tablets, for oral use INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-05-062681513838
8a73e1339-9643-4eea-2cbe-e879c88fb50e (view SPL)These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) TABLETSINITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionAstrazeneca Lp2015-02-0618001860004, 001860008, 001860016, 001860032
9be36901a-b2fe-5834-755b-9a44e6748890 (view SPL)These highlights do not include all the information needed to use CANDESARTAN CILEXETIL tablets safely and effectively. See full prescribing information for CANDESARTAN CILEXETIL tablets. CANDESARTAN CILEXETIL tablets , for oral use INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-03-113605053618, 605053619, 605053620, 605053621
10c4102f20-07fc-47ec-9c02-51b9578fbedf (view SPL)These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636293376
11d0c94743-cb17-4581-962e-7add11ae52e7 (view SPL)ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998 These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-04-262681514145
12f61ff26d-a310-43cc-981a-da02e3d786a9 (view SPL)These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998prescriptionHuman PrescriptionCardinal HealthREPACK2013-03-282551549610
13fd676896-5f5b-48da-becc-3736a6fc1f14 (view SPL)ATACAND (candesartan cilexetil) TABLETS INITIAL U.S. APPROVAL: 1998 These highlights do not include all the information needed to use ATACAND safely and effectively. See full prescribing information for ATACAND. prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-04-262681514146

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII