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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209500
Company: INTRA-CELLULAR

Medication Guide

Products on NDA 209500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPLYTA	LUMATEPERONE TOSYLATE	EQ 42MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes
CAPLYTA	LUMATEPERONE TOSYLATE	EQ 10.5MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
CAPLYTA	LUMATEPERONE TOSYLATE	EQ 21MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209500Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209500Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209500s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209500Orig1s011ltr.pdf
04/26/2022	SUPPL-9		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s009lbl.pdf
12/17/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209500Orig1s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209500Orig1s006_Redacted.pdf
12/17/2021	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209500Orig1s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/209500Orig1s005_Redacted.pdf
12/20/2019	SUPPL-1		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209500s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209500Orig1s000ltr.pdf

Labels for NDA 209500

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/28/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209500s011lbl.pdf
06/28/2023	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209500s011lbl.pdf
04/26/2022	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209500s009lbl.pdf
12/17/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf
12/17/2021	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf
12/20/2019	SUPPL-1	Type 1 - New Molecular Entity	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209500s000lbl.pdf

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