FDA.reportPublic FDA data

Application 217678

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BINIMETINIBBINIMETINIBTABLET;ORAL15MGNoNo

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78596ORIG 2024-05-31