FDA.reportPublic FDA data

Application 213092

Type
NDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LENVATINIBLENVATINIBCAPSULE; ORAL4MGNoNo
002LENVATINIBLENVATINIBCAPSULE; ORAL10MGNoNo

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
LenvimaLENVATINIBEisai Inc.f4bedd21-efde-44c6-9d9c-b48b78d7ed1e2026-06-30Warnings, Adverse reactionsName fallback
generic name: LENVATINIB

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71705ORIG2022-08-03