Ketoconazole Oral Tablet

Brand(s)
Nizoral
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-06-24)
Oldest Current Product
1981-06-12
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\KETOCONAZOLE
FDAOB
ORAL\TABLET\KETOCONAZOLE
SPL Active
ORAL\TABLET\KETOCONAZOLE
SPL Moiety
ORAL\TABLET\KETOCONAZOLE

product(s) by strength(s)

ketoconazole 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930900ANDATeva Pharmaceuticals Usa Inc1999-06-15KETOCONAZOLEORALTABLETANDA07527391fffa92-709a-4e16-9335-e6f0338a5eb9
2003780261ANDAMylan Pharmaceuticals Inc.2000-02-23KETOCONAZOLEORALTABLETANDA07559746698e84-8dd2-4faf-aaf0-d7cddfebb71f
3516724026ANDATaro Pharmaceuticals U.S.A., Inc.1999-06-15KETOCONAZOLEORALTABLETANDA0753198ca815a8-bccb-4ee2-a042-922373329cae

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580220NizoralNDAJanssen Pharmaceuticals, Inc.1981-06-12KETOCONAZOLEORALTABLETNDA018533090660c1-6e6d-457f-adb5-046ddfcd1465

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790055ANDAKaiser Foundations Hospitals2010-03-02KETOCONAZOLEORALTABLET003780261ANDA075597e7fae084-8770-4266-b6f9-db86d2c6d395
2165900998ANDAStat Rx Usa Llc2011-05-31KETOCONAZOLEORALTABLET000930900ANDA075273d9dd50aa-e8d9-4839-ae92-26135415357e
3216950562ANDARebel Distributors Corp1999-06-15KETOCONAZOLEORALTABLET516724026ANDA075319ec308fcf-ec39-43af-97e3-98aa8ab997f4
4332610739ANDAAidarex Pharmaceuticals Llc1999-06-15KETOCONAZOLEORALTABLET516724026ANDA075319092f1cea-edf2-4536-b378-34b28e281b83
5430630036ANDAPd-Rx Pharmaceuticals, Inc.2011-05-20KETOCONAZOLEORALTABLET003780261ANDA0755972156eee8-4e76-454e-8187-94f1514a77ec
6493490379ANDARemedyrepack Inc.2011-07-14KETOCONAZOLEORALTABLET003780261ANDA075597ed8cd4ef-b233-4770-b8ca-e02ba73a1506
7499990301ANDALake Erie Medical Dba Quality Care Products Llc1999-06-15KETOCONAZOLEORALTABLET000930900ANDA07527372c743b9-cb85-46e8-873a-b84e6d1b5250
8521250086ANDARemedyrepack Inc.2013-03-15KETOCONAZOLEORALTABLET000930900ANDA07527378cbad6d-8b12-42a6-b160-9e787c441806
9538080842ANDAState Of Florida Doh Central Pharmacy2013-01-01KETOCONAZOLEORALTABLET003780261ANDA07559770ec9dd0-8c93-4ac5-b872-f426c9ae4b98
10548685071ANDAPhysicians Total Care, Inc.2004-05-24KETOCONAZOLEORALTABLET516724026ANDA075319e96fcf16-543e-4a02-9dac-afad20f79108
11604290020ANDAGolden State Medical Supply, Inc.2009-05-20KETOCONAZOLEORALTABLET516724026ANDA075319a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7
12636291485ANDABryant Ranch Prepack1999-06-15KETOCONAZOLEORALTABLET000930900ANDA0752735143ebc7-c72e-4fd4-aea2-4d337e564c67
13680840552ANDAAmerican Health Packaging2012-01-20KETOCONAZOLEORALTABLET003780261ANDA0755971b515565-a311-4d1a-a2ce-02b16bdb74a5
14681512713ANDACarilion Materials Management1999-06-15KETOCONAZOLEORALTABLET000930900ANDA075273be550113-f75c-4aec-86ed-c4a0c1a6f704
15687889117ANDAPreferred Pharmaceuticals, Inc.2011-05-31KETOCONAZOLEORALTABLET000930900ANDA075273be3eb758-2659-4f8b-abb7-cc57740e7331
16687889708ANDAPreferred Pharmaceuticals, Inc.2013-02-05KETOCONAZOLEORALTABLET516724026ANDA075319760ddedd-9ae6-452c-8e10-e91c5baffd09

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074971KETOCONAZOLETrueTEVA PHARMACEUTICALS USA INC1999-06-15ANDA074971_001
2ANDA075273KETOCONAZOLETEVA PHARMACEUTICALS USA INC1999-06-15ANDA075273_001
3ANDA075314KETOCONAZOLETrueMUTUAL PHARMACAL CO1999-06-15ANDA075314_001
4ANDA075319KETOCONAZOLETARO PHARMACEUTICAL INDUSTRIES LTD1999-06-15ANDA075319_001
5ANDA075341KETOCONAZOLETrueAAIPHARMA LLC1999-07-27ANDA075341_001
6ANDA075362KETOCONAZOLETruePLIVA INC1999-06-15ANDA075362_001
7ANDA075597KETOCONAZOLEMYLAN PHARMACEUTICALS INC1999-12-23ANDA075597_001
8ANDA075912KETOCONAZOLETrueAPOTEX INC2002-01-10ANDA075912_001
9NDA018533NIZORALTrueJANSSEN PHARMACEUTICALS INCNDA018533_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074971_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalse1999-06-15KETOCONAZOLE
2ANDA075273_001RXKETOCONAZOLE (200MG)ORALTABLETTrueAB1999-06-15KETOCONAZOLE
3ANDA075314_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalse1999-06-15KETOCONAZOLE
4ANDA075319_001RXKETOCONAZOLE (200MG)ORALTABLETFalseAB1999-06-15KETOCONAZOLE
5ANDA075341_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalse1999-07-27KETOCONAZOLE
6ANDA075362_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalse1999-06-15KETOCONAZOLE
7ANDA075597_001RXKETOCONAZOLE (200MG)ORALTABLETFalseAB1999-12-23KETOCONAZOLE
8ANDA075912_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalse2002-01-10KETOCONAZOLE
9NDA018533_001discontinuedKETOCONAZOLE (200MG)ORALTABLETFalseNIZORAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1090660c1-6e6d-457f-adb5-046ddfcd1465 (view SPL)NIZORAL (KETOCONAZOLE)TABLETSprescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-03-073504580220
2092f1cea-edf2-4536-b378-34b28e281b83 (view SPL)KetoconazoleTablets USP,200 MGprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-051332610739
31b515565-a311-4d1a-a2ce-02b16bdb74a5 (view SPL)prescriptionHuman PrescriptionAmerican Health PackagingREPACK2012-01-201680840552
42156eee8-4e76-454e-8187-94f1514a77ec (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack1999-09-164430630036
546698e84-8dd2-4faf-aaf0-d7cddfebb71f (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-04-168003780261
65143ebc7-c72e-4fd4-aea2-4d337e564c67 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg0900prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636291485
770ec9dd0-8c93-4ac5-b872-f426c9ae4b98 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-121538080842
872c743b9-cb85-46e8-873a-b84e6d1b5250 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg0900prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-131499990301
9760ddedd-9ae6-452c-8e10-e91c5baffd09 (view SPL)Ketoconazole Tablets USP, 200 MGprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-06-112687889708
1078cbad6d-8b12-42a6-b160-9e787c441806 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg0900prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-151521250086
118ca815a8-bccb-4ee2-a042-922373329cae (view SPL)Ketoconazole Tablets USP, 200 MGprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-04-155516724026
1291fffa92-709a-4e16-9335-e6f0338a5eb9 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg0900Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-06-248000930900
13a9fc4618-4d87-47ef-ab3c-c9ffac3ba9b7 (view SPL)KETOCONAZOLE TABLETS USP, 200 mgprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-05-194604290020
14be3eb758-2659-4f8b-abb7-cc57740e7331 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg 0900 Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-06-112687889117
15be550113-f75c-4aec-86ed-c4a0c1a6f704 (view SPL)KETOCONAZOLE TABLETS USP, 200 mg 0900 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-04-032681512713
16d9dd50aa-e8d9-4839-ae92-26135415357e (view SPL)KETOCONAZOLE TABLETS USP, 200 mg0900prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-09-081165900998
17e7fae084-8770-4266-b6f9-db86d2c6d395 (view SPL)KETOCONAZOLE TABLETS, USP200 mgprescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2010-04-201001790055
18e96fcf16-543e-4a02-9dac-afad20f79108 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-03-101548685071
19ec308fcf-ec39-43af-97e3-98aa8ab997f4 (view SPL)KETOCONAZOLE TABLETS USP, 200 mgprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-291216950562
20ed8cd4ef-b233-4770-b8ca-e02ba73a1506 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-141493490379

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