FDA.reportPublic FDA data

Application 219085

Type
ANDA
Sponsor
AUROBINDO PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUMATEPERONELUMATEPERONECAPSULE 42MGNoNo
002LUMATEPERONELUMATEPERONECAPSULE14MGNoNo
003LUMATEPERONELUMATEPERONECAPSULE28MGNoNo
004LUMATEPERONELUMATEPERONECAPSULE10.5MGNoNo
005LUMATEPERONELUMATEPERONECAPSULE21MGNoNo

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
CAPLYTALUMATEPERONEIntra-Cellular Therapies, Incdb730b06-6351-47fd-8183-e61e61bbead52025-06-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LUMATEPERONE