FDA.reportPublic FDA data

Application 213400

Type
NDA
Sponsor
EPIZYME INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZVERIKTAZEMETOSTAT HYDROBROMIDETABLET;ORAL200MGYesNo

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
TAZVERIKTAZEMETOSTATEpizyme, Inc.7db07b5f-4e22-467c-9c0a-f830b08dbb1d2026-04-29Warnings, Adverse reactionsName fallback
brand name: TAZVERIK

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65390ORIG2020-11-30
63625ORIG2020-06-19
63615ORIG2020-06-18
63614ORIG2020-06-18