FDA.reportPublic FDA data

Application 219386

Type
ANDA
Sponsor
HETERO LABS LTD UNIT III

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUVOREXANTSUVOREXANTTABLET5MGNoNo
002SUVOREXANTSUVOREXANTTABLET10MGNoNo
003SUVOREXANTSUVOREXANTTABLET15MGNoNo
004SUVOREXANTSUVOREXANTTABLET20MGNoNo

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
BELSOMRASUVOREXANTMerck Sharp & Dohme LLCe5b72731-1acb-45b7-9c13-290ad12d39512025-03-10Warnings, Adverse reactionsName fallback
generic name: SUVOREXANT