FDA.reportPublic FDA data

Application 020694

Type
NDA
Sponsor
JANSSEN PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPORANOXITRACONAZOLECAPSULE; ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ItraconazoleITRACONAZOLERising Pharma Holdings, Inc.6df5ff94-47ba-4881-abb4-b321e35a69552026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLEAmneal Pharmaceuticals LLC43ded1aa-f825-40fe-aa9a-addd36a07f062026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ITRACONAZOLEITRACONAZOLEAlembic Pharmaceuticals Inc.23126370-8d6a-4027-bd8f-860e2776ba3a2026-07-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLETorrent Pharmaceuticals Limitedb1274d78-1096-4ae3-8299-a2e94eaa0ea52026-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLEAmneal Pharmaceuticals LLC2ab38a8a-3708-4b97-9f7f-8e554a15348d2026-07-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
SPORANOXITRACONAZOLEJanssen Pharmaceuticals, Inc.a4d555fa-787c-40fb-bb7d-b0d4f7318fd02026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SPORANOX
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLEAvPAK68165d90-953c-e2f5-e053-2a91aa0ada252026-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLEAscend Laboratories, LLC349ffcf4-b2cd-4c93-9411-13c39275b8f32025-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
TolsuraITRACONAZOLEMayne Pharma Commercial LLC306352d1-9d5a-49ad-b72d-893b995468612025-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLEAmerican Health Packaginge564067e-e469-4c51-9076-75f89f5c5cdf2025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLECamber Pharmaceuticals, Inc.5af0b33d-bfa6-420b-86f0-067f95b402b22025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
itraconazoleITRACONAZOLEPatriot Pharmaceuticals6242b7ad-eaa0-a524-b6e0-ec33e63407db2025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ItraconazoleITRACONAZOLENorthStar RxLLC46732a10-1f0d-4022-9689-256c44683e962023-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
Itraconazole OralITRACONAZOLENatco Pharma USA LLCda63870d-b426-4e49-9591-5bb51f962e662023-08-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE
ITRACONAZOLEITRACONAZOLEAlembic Pharmaceuticals Limitedf9d8b5a7-435f-40e6-8596-5f2376b92c742023-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ITRACONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20829ORIG2010-01-05