CAPLYTA

CAPLYTA

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 829572556

Effective Date

January 12, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Lumateperone(42 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

70518-3497

Application Number

NDA209500

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

Code: 70BSQ12069Class: ACTIBQuantity: 42 mg in 1 1