FDA.reportPublic FDA data

Application 217509

Type
ANDA
Sponsor
TEVA PHARMACEUTICALS USA, INC.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BINIMETINIBBINIMETINIBTABLET15MGNoNo

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
MEKTOVIBINIMETINIBArray BioPharma Inc.6c3408ac-d401-4925-8a03-26591afbc2402025-03-20Warnings, Adverse reactionsName fallback
generic name: BINIMETINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81195ORIG 2025-02-10