FDA.reportPublic FDA data

Application 220712

Type
NDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KITPROZYCARFILZOMIBVIAL; SINGLE-USE60MG/ML, 2/MLNoNo
002KITPROZYCARFILZOMIBVIAL; SINGLE-USE120MG/2ML (60MG/ML), 2MLNoNo

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
KYPROLISCARFILZOMIBOnyx Pharmaceuticals, Inc.ea66eb30-e665-4693-99a1-a9d3b4bbe2d62025-06-18Warnings, Adverse reactionsName fallback
generic name: CARFILZOMIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85458ORIG 2026-03-23