FDA.reportPublic FDA data

Application 213576

Type
ANDA
Sponsor
MSN PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELUXADOLINEELUXADOLINETABLET;ORAL75MGNoNo
002ELUXADOLINEELUXADOLINETABLET;ORAL100MGNoNo

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
ViberziELUXADOLINEAllergan, Inc.7821bd40-4c84-4984-951b-6436ae20421a2024-07-16Warnings, Adverse reactionsName fallback
generic name: ELUXADOLINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68926ORIG2021-10-08