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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209500
Company: INTRA-CELLULAR
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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