FDA.reportPublic FDA data

Application 219229

Type
ANDA
Sponsor
DR. REDDY'S LABORATORIES LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUMATEPERONELUMATEPERONECAPSULE10.5MGNoNo
002LUMATEPERONELUMATEPERONECAPSULE21MGNoNo
005LUMATEPERONELUMATEPERONECAPSULE42MGNoNo

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