Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209500

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CAPLYTA (LUMATEPERONE TOSYLATE)
EQ 10.5MG BASE
Marketing Status: Prescription

Active Ingredient: LUMATEPERONE TOSYLATE
Proprietary Name: CAPLYTA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 10.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209500
Product Number: 002
Approval Date: Apr 22, 2022
Applicant Holder Full Name: INTRA-CELLULAR THERAPIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CAPLYTA (LUMATEPERONE TOSYLATE)
EQ 21MG BASE
Marketing Status: Prescription

Active Ingredient: LUMATEPERONE TOSYLATE
Proprietary Name: CAPLYTA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 21MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209500
Product Number: 003
Approval Date: Apr 22, 2022
Applicant Holder Full Name: INTRA-CELLULAR THERAPIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CAPLYTA (LUMATEPERONE TOSYLATE)
EQ 42MG BASE
Marketing Status: Prescription

Active Ingredient: LUMATEPERONE TOSYLATE
Proprietary Name: CAPLYTA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 42MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209500
Product Number: 001
Approval Date: Dec 20, 2019
Applicant Holder Full Name: INTRA-CELLULAR THERAPIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information