FDA.reportPublic FDA data

Application 219473

Type
ANDA
Sponsor
AUROBINDO PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CENOBAMATECENOBAMATETABLET50MGNoNo
003CENOBAMATECENOBAMATETABLET200MGNoNo
004CENOBAMATECENOBAMATETABLET100MGNoNo
005CENOBAMATECENOBAMATETABLET25MGNoNo
006CENOBAMATECENOBAMATETABLET12.5MGNoNo

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
XcopriCENOBAMATESK Life Science, Inc.565c2126-57ae-4e29-b443-723bbe7e20722025-09-25Warnings, Adverse reactionsName fallback
generic name: CENOBAMATE