Itraconazole Oral Capsule

Brand(s)
Sporanox
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Patriot Pharmaceuticals, Llc (2015-05-21)
Oldest Current Product
1992-09-11
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\ITRACONAZOLE
FDAOB
ORAL\CAPSULE\ITRACONAZOLE
SPL Active
ORAL\CAPSULE\ITRACONAZOLE
SPL Moiety
ORAL\CAPSULE\ITRACONAZOLE

product(s) by strength(s)

itraconazole 100 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101471700NDAPatriot Pharmaceuticals, Llc2005-02-01ITRACONAZOLEORALCAPSULENDA0200836242b7ad-eaa0-a524-b6e0-ec33e63407db

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001850550ANDAEon Labs, Inc.2004-05-28ITRACONAZOLEORALCAPSULEANDA076104599dcdd0-df9b-41e2-a767-b1f44f466fbd
2003785100ANDAMylan Pharmaceuticals Inc.2012-07-20ITRACONAZOLEORALCAPSULEANDA200463d343050e-00bb-440c-a24b-7cd18c97e184

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1636291647SporanoxNDABryant Ranch Prepack1992-09-11ITRACONAZOLEORALCAPSULE504580290NDA020083237b41bc-8290-4e01-8eee-8d72b73e9366
2681512718NDACarilion Materials Management2005-02-01ITRACONAZOLEORALCAPSULE101471700NDA02008331735974-a7ac-42b5-8ce1-4d8dc2808c3a

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076104ITRACONAZOLESANDOZ INC2004-05-28ANDA076104_001
2ANDA200463ITRACONAZOLEMYLAN PHARMACEUTICALS INC2012-07-20ANDA200463_001
3NDA020083SPORANOXJANSSEN PHARMACEUTICALS INC1992-09-11NDA020083_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076104_001RXITRACONAZOLE (100MG)ORALCAPSULEFalseAB2004-05-28ITRACONAZOLE
2ANDA200463_001RXITRACONAZOLE (100MG)ORALCAPSULEFalseAB2012-07-20ITRACONAZOLE
3NDA020083_001RXITRACONAZOLE (100MG)ORALCAPSULETrueAB1992-09-11SPORANOX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1237b41bc-8290-4e01-8eee-8d72b73e9366 (view SPL)SPORANOX (itraconazole) CapsulesprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-211000636291647
231735974-a7ac-42b5-8ce1-4d8dc2808c3a (view SPL)Itraconazole CapsulesprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-07-292681512718
3599dcdd0-df9b-41e2-a767-b1f44f466fbd (view SPL)ITRACONAZOLE CAPSULESprescriptionHuman PrescriptionEon Labs, Inc.2015-10-2132001850550
46242b7ad-eaa0-a524-b6e0-ec33e63407db (view SPL)Itraconazole CapsulesprescriptionHuman PrescriptionPatriot Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2015-05-219101471700
5a4d555fa-787c-40fb-bb7d-b0d4f7318fd0 (view SPL)SPORANOX (itraconazole) CapsulesprescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.API MANUFACTURE, MANUFACTURE, PACK2015-04-2310504580290
6d343050e-00bb-440c-a24b-7cd18c97e184 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-134003785100

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