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
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
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
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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