cilostazol Oral Tablet

Brand(s)
Pletal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Otsuka America Pharmaceutical, Inc. (2015-07-30)
Oldest Current Product
1999-01-15
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\CILOSTAZOL
FDAOB
ORAL\TABLET\CILOSTAZOL
SPL Active
ORAL\TABLET\CILOSTAZOL
SPL Moiety
ORAL\TABLET\CILOSTAZOL

product(s) by strength(s)

cilostazol 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480002PletalNDAOtsuka America Pharmaceutical, Inc.1999-01-15CILOSTAZOLORALTABLETNDA02086324d75b58-bafb-4440-b8d7-4f4079c08b0b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540044ANDARoxane Laboratories, Inc2011-01-05CILOSTAZOLORALTABLETANDA0770249ffdb1e8-fdc8-44d4-b558-210954138b2f
2000932064ANDATeva Pharmaceuticals Usa Inc2012-10-24CILOSTAZOLORALTABLETANDA077027a6292311-9cb2-49ff-b8bf-12e2dbd196cd
3001850223ANDAEon Labs, Inc.2004-11-23CILOSTAZOLORALTABLETANDA07702126610bfe-4c3c-4c20-8b6d-b7c18cd6fe23
4185270120ANDABiokey Inc.2014-04-01CILOSTAZOLORALTABLETANDA0778317496843f-0c4d-46e1-af23-850213b38f9e
5519910168ANDABreckenridge Pharmaceutical, Inc.2009-09-28CILOSTAZOLORALTABLETANDA077708c4597231-fec0-435d-a0c6-8c237e3d60a9
6605052522ANDAApotex Corp2011-10-18CILOSTAZOLORALTABLETANDA077030ceac1ae3-c343-28ca-c083-b748d21a15e6

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900285ANDAStat Rx Usa Llc2006-09-06CILOSTAZOLORALTABLET647200159ANDA0770221eb9a361-cd8d-44b0-bf40-42b97a470ddd
2548685411ANDAPhysicians Total Care, Inc.2005-09-09CILOSTAZOLORALTABLET647200159ANDA077022151d1497-7655-44ce-8e97-dd1cd91f686a
3604290763ANDAGolden State Medical Supply, Inc.2006-09-06CILOSTAZOLORALTABLET647200159ANDA077022b4509afc-539b-4d7f-97d4-5e9c98c2f65a
4647200159ANDACorepharma, Llc2006-09-06CILOSTAZOLORALTABLETANDA0770221162b345-b45c-448e-a399-b3cce63ea37b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157713ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-03-23CILOSTAZOLORALTABLET000937231ANDA0770275f4fc5df-5077-4cad-a5dc-1b54a73904cc
2006157747ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-03-23CILOSTAZOLORALTABLET000932064ANDA07702766e0ed7b-e29a-45ee-82bb-3db6142c2697
3353560951ANDALake Erie Medical Dba Quality Care Products Llc2011-10-18CILOSTAZOLORALTABLET605052522ANDA07703020a05739-46a6-47ca-ae61-4341d028460e
4353560990ANDALake Erie Medical Dba Quality Care Products Llc2012-10-24CILOSTAZOLORALTABLET000932064ANDA077027f86d303a-eaa2-4335-bfce-1952404ae96c
5551546671ANDACardinal Health2011-10-18CILOSTAZOLORALTABLET605052522ANDA07703085fc5079-ec88-450e-9c0b-bca7340cad4f
6604290363ANDAGolden State Medical Supply, Inc.2011-10-18CILOSTAZOLORALTABLET605052522ANDA077030d801230d-0344-4cea-bb04-5818e931bb66
7636295112ANDABryant Ranch Prepack2004-11-23CILOSTAZOLORALTABLET001850223ANDA077021c9866259-deab-46af-b8e6-880dba7bfb96
8681514123ANDACarilion Materials Management2011-01-05CILOSTAZOLORALTABLET000540044ANDA07702450fc64ac-7eb3-4bab-8de2-83cd5404d169
9687889380ANDAPreferred Pharmaceuticals, Inc.2014-07-28CILOSTAZOLORALTABLET605052522ANDA0770306a8b9b84-9942-4edd-8df9-319880d2feab

cilostazol 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1591480003PletalNDAOtsuka America Pharmaceutical, Inc.1999-01-15CILOSTAZOLORALTABLETNDA02086324d75b58-bafb-4440-b8d7-4f4079c08b0b

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540028ANDARoxane Laboratories, Inc2005-05-17CILOSTAZOLORALTABLETANDA0770249ffdb1e8-fdc8-44d4-b558-210954138b2f
2000932065ANDATeva Pharmaceuticals Usa Inc2012-04-24CILOSTAZOLORALTABLETANDA077027a6292311-9cb2-49ff-b8bf-12e2dbd196cd
3001850123ANDAEon Labs, Inc.2005-11-08CILOSTAZOLORALTABLETANDA07731026610bfe-4c3c-4c20-8b6d-b7c18cd6fe23
4185270119ANDABiokey Inc.2014-04-01CILOSTAZOLORALTABLETANDA0777227496843f-0c4d-46e1-af23-850213b38f9e
5519910167ANDABreckenridge Pharmaceutical, Inc.2009-09-28CILOSTAZOLORALTABLETANDA077708c4597231-fec0-435d-a0c6-8c237e3d60a9
6605052521ANDAApotex Corp2011-10-18CILOSTAZOLORALTABLETANDA077030ceac1ae3-c343-28ca-c083-b748d21a15e6

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1604290762ANDAGolden State Medical Supply, Inc.2006-09-06CILOSTAZOLORALTABLET647200158ANDA077150b4509afc-539b-4d7f-97d4-5e9c98c2f65a
2647200158ANDACorepharma, Llc2006-09-06CILOSTAZOLORALTABLETANDA0771501162b345-b45c-448e-a399-b3cce63ea37b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157716ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-06-26CILOSTAZOLORALTABLET000932065ANDA07702766e0ed7b-e29a-45ee-82bb-3db6142c2697
2551548287ANDACardinal Health2011-02-18CILOSTAZOLORALTABLET000937230ANDA0770278e49409b-6bb1-4b8a-8a5b-4cb1a291660e
3604290362ANDAGolden State Medical Supply, Inc.2011-10-18CILOSTAZOLORALTABLET605052521ANDA077030d801230d-0344-4cea-bb04-5818e931bb66
4636294644ANDABryant Ranch Prepack2005-05-17CILOSTAZOLORALTABLET000540028ANDA07702481d39216-a241-4ab1-8937-171f96c28f3c
5680840779ANDAAmerican Health Packaging2014-07-30CILOSTAZOLORALTABLET605052521ANDA077030f1ccc10a-e42d-44f7-b7da-5538f3b39461
6681513844ANDACarilion Materials Management2005-05-17CILOSTAZOLORALTABLET000540028ANDA077024eb510ad0-dce7-4714-afc6-7959a151ad28

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA077019CILOSTAZOLMYLAN PHARMACEUTICALS INC2004-11-23ANDA077019_001, ANDA077019_002
2ANDA077020CILOSTAZOLTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA2005-03-01ANDA077020_002
3ANDA077021CILOSTAZOLSANDOZ INC2004-11-23ANDA077021_001
4ANDA077022CILOSTAZOLTrueCOREPHARMA LLC2004-11-23ANDA077022_001
5ANDA077024CILOSTAZOLROXANE LABORATORIES INC2005-05-17ANDA077024_001, ANDA077024_002
6ANDA077027CILOSTAZOLTEVA PHARMACEUTICALS USA INC2004-11-24ANDA077027_001, ANDA077027_002
7ANDA077028CILOSTAZOLTrueACTAVIS ELIZABETH LLC2004-11-26ANDA077028_002
8ANDA077030CILOSTAZOLAPOTEX INC ETOBICOKE SITE2004-12-10ANDA077030_001, ANDA077030_002
9ANDA077150CILOSTAZOLTrueCOREPHARMA LLC2005-03-11ANDA077150_001
10ANDA077208CILOSTAZOLTrueMUTUAL PHARMACEUTICAL CO INC2006-03-29ANDA077208_001, ANDA077208_002
11ANDA077310CILOSTAZOLSANDOZ INC2005-11-08ANDA077310_001
12ANDA077323CILOSTAZOLMYLAN PHARMACEUTICALS INC2006-04-20ANDA077323_001, ANDA077323_002
13ANDA077708CILOSTAZOLBRECKENRIDGE PHARMACEUTICAL INC2009-09-28ANDA077708_001, ANDA077708_002
14ANDA077722CILOSTAZOLBIOKEY INC2012-09-24ANDA077722_001
15ANDA077831CILOSTAZOLBIOKEY INC2012-09-24ANDA077831_001
16ANDA077898CILOSTAZOLPLIVA HRVATSKA DOO2007-10-29ANDA077898_001, ANDA077898_002
17NDA020863PLETALOTSUKA PHARMACEUTICAL CO LTD1999-01-15NDA020863_001, NDA020863_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077019_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2004-11-23CILOSTAZOL
2ANDA077019_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2004-11-23CILOSTAZOL
3ANDA077020_002discontinuedCILOSTAZOL (100MG)ORALTABLETFalse2005-03-01CILOSTAZOL
4ANDA077021_001RXCILOSTAZOL (100MG)ORALTABLETFalseAB2004-11-23CILOSTAZOL
5ANDA077022_001discontinuedCILOSTAZOL (100MG)ORALTABLETFalse2004-11-23CILOSTAZOL
6ANDA077024_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2005-05-17CILOSTAZOL
7ANDA077024_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2005-05-17CILOSTAZOL
8ANDA077027_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2004-11-24CILOSTAZOL
9ANDA077027_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2004-11-24CILOSTAZOL
10ANDA077028_002discontinuedCILOSTAZOL (100MG)ORALTABLETFalse2004-11-26CILOSTAZOL
11ANDA077030_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2004-12-10CILOSTAZOL
12ANDA077030_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2004-12-10CILOSTAZOL
13ANDA077150_001discontinuedCILOSTAZOL (50MG)ORALTABLETFalse2005-03-11CILOSTAZOL
14ANDA077208_001discontinuedCILOSTAZOL (100MG)ORALTABLETFalse2006-03-29CILOSTAZOL
15ANDA077208_002discontinuedCILOSTAZOL (50MG)ORALTABLETFalse2006-03-29CILOSTAZOL
16ANDA077310_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2005-11-08CILOSTAZOL
17ANDA077323_001RXCILOSTAZOL (100MG)ORALTABLETFalseAB2006-04-20CILOSTAZOL
18ANDA077323_002RXCILOSTAZOL (50MG)ORALTABLETFalseAB2006-04-20CILOSTAZOL
19ANDA077708_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2009-09-28CILOSTAZOL
20ANDA077708_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2009-09-28CILOSTAZOL
21ANDA077722_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2012-09-24CILOSTAZOL
22ANDA077831_001RXCILOSTAZOL (100MG)ORALTABLETFalseAB2012-09-24CILOSTAZOL
23ANDA077898_001RXCILOSTAZOL (50MG)ORALTABLETFalseAB2007-10-29CILOSTAZOL
24ANDA077898_002RXCILOSTAZOL (100MG)ORALTABLETFalseAB2007-10-29CILOSTAZOL
25NDA020863_001RXCILOSTAZOL (50MG)ORALTABLETTrueAB1999-01-15PLETAL
26NDA020863_002RXCILOSTAZOL (100MG)ORALTABLETTrueAB1999-01-15PLETAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11162b345-b45c-448e-a399-b3cce63ea37b (view SPL)Cilostazol Tablets, USP50 mg and 100 mgRx onlyprescriptionHuman PrescriptionCorepharma, Llc2011-11-289647200158, 647200159
2151d1497-7655-44ce-8e97-dd1cd91f686a (view SPL)Cilostazol Tablets, USP50 mg and 100 mgRx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-152548685411
31eb9a361-cd8d-44b0-bf40-42b97a470ddd (view SPL)Cilostazol Tablets50 mg and 100 mgRx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-03-121165900285
420a05739-46a6-47ca-ae61-4341d028460e (view SPL)CILOSTAZOL TABLETS, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcREPACK2013-08-061353560951
524d75b58-bafb-4440-b8d7-4f4079c08b0b (view SPL)These highlights do not include all the information needed to use PLETAL safely and effectively. See full prescribing information for PLETAL. PLETAL (cilostazol) tablets, for oral use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionOtsuka America Pharmaceutical, Inc.2015-07-308591480002, 591480003
626610bfe-4c3c-4c20-8b6d-b7c18cd6fe23 (view SPL)These highlights do not include all the information needed to use cilostazol tablets safely and effectively. See full prescribing information for cilostazol tablets.CILOSTAZOL tablets, for oral use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionEon Labs, Inc.2015-09-2218001850123, 001850223
750fc64ac-7eb3-4bab-8de2-83cd5404d169 (view SPL)Cilostazol Tablets USP, 50 mg and 100 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-05-312681514123
85f4fc5df-5077-4cad-a5dc-1b54a73904cc (view SPL)CILOSTAZOL TABLETS Rx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-10-1013006157713
966e0ed7b-e29a-45ee-82bb-3db6142c2697 (view SPL)CILOSTAZOL TABLETS USPRx onlyRev. K 6/2012prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-10-096006157716, 006157747
106a8b9b84-9942-4edd-8df9-319880d2feab (view SPL)CILOSTAZOL TABLETS, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-07-301687889380
117496843f-0c4d-46e1-af23-850213b38f9e (view SPL)Cilostazol Tablets, USP 50 mg and 100 mg Rx onlyprescriptionHuman PrescriptionBiokey Inc.2013-08-1510185270119, 185270120
1281d39216-a241-4ab1-8937-171f96c28f3c (view SPL)Cilostazol Tablets USP, 50 mg and 100 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636294644
1385fc5079-ec88-450e-9c0b-bca7340cad4f (view SPL)CILOSTAZOL TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2013-11-112551546671
148e49409b-6bb1-4b8a-8a5b-4cb1a291660e (view SPL)CILOSTAZOL TABLETS72307231Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2012-02-021551548287
159ffdb1e8-fdc8-44d4-b558-210954138b2f (view SPL)Cilostazol Tablets USP, 50 mg and 100 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-02-0312000540028, 000540044
16a6292311-9cb2-49ff-b8bf-12e2dbd196cd (view SPL)These highlights do not include all the information needed to use CILOSTAZOL TABLETS USP safely and effectively. See full prescribing information for CILOSTAZOL TABLETS USP.CILOSTAZOL tablets, for oral useInitial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-187000932064, 000932065
17b4509afc-539b-4d7f-97d4-5e9c98c2f65a (view SPL)Cilostazol Tablets, USP50 mg and 100 mgRx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-03-272604290762, 604290763
18c4597231-fec0-435d-a0c6-8c237e3d60a9 (view SPL)CILOSTAZOL TABLETS(sil-OS-tah-zol)prescriptionHuman PrescriptionBreckenridge Pharmaceutical, Inc.MANUFACTURE2013-08-225519910167, 519910168
19c9866259-deab-46af-b8e6-880dba7bfb96 (view SPL)Cilostazol TabletsprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-11-121000636295112
20ceac1ae3-c343-28ca-c083-b748d21a15e6 (view SPL)These highlights do not include all the information needed to use CILOSTAZOL TABLETS, USP safely and effectively. See full prescribing information for CILOSTAZOL TABLETS, USP. CILOSTAZOL tablets, for oral use. Initial U.S. Approval: 1999prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-08-275605052521, 605052522
21d801230d-0344-4cea-bb04-5818e931bb66 (view SPL)Physician Prescribing Information Rx ONLY. CILOSTAZOL TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2015-05-012604290362, 604290363
22eb510ad0-dce7-4714-afc6-7959a151ad28 (view SPL)Cilostazol Tablets USP, 50 mg and 100 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-05-312681513844
23f1ccc10a-e42d-44f7-b7da-5538f3b39461 (view SPL)CILOSTAZOL TABLETS, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-11-093680840779
24f86d303a-eaa2-4335-bfce-1952404ae96c (view SPL)CILOSTAZOL Tablets USP20652064prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2013-07-291353560990

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