FDA.reportPublic FDA data

Application 206545

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYDELIGIDELALISIBTABLET;ORAL100MGYesNo
002ZYDELIGIDELALISIBTABLET;ORAL150MGYesNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZydeligIDELALISIBGilead Sciences, Inc.efbdafa9-d18c-4e85-b4a2-1e620fc74e502025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Zydelig
generic name: IDELALISIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43524ORIG2014-08-13
24520ORIG2014-08-13
44602ORIG2014-08-01
32815ORIG2014-07-23
19724ORIG2014-07-23