FDA.reportPublic FDA data

Application 216242

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CRISABOROLECRISABOROLEOINTMENT2%NoNo

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
EucrisaCRISABOROLEPfizer Laboratories Div Pfizer Inc609b77de-1ca3-4783-b8f5-01a9c0f1d77d2025-09-23Warnings, Adverse reactionsName fallback
generic name: CRISABOROLE

Reported adverse events (FAERS/openFDA)#

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