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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212576
Company: OTSUKA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INQOVI CEDAZURIDINE; DECITABINE 100MG;35MG TABLET;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
07/07/2020 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212576s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212576Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212576Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/24/2022 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212576s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212576Orig1s003ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/24/2022 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212576s003lbl.pdf
07/07/2020 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212576s000lbl.pdf
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