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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206709
Company: BIOCODEX SA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIACOMIT STIRIPENTOL 250MG CAPSULE;ORAL Prescription None Yes No
DIACOMIT STIRIPENTOL 500MG 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
08/20/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206709Orig1s000,207223Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2022 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206709s003;207223s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206709Orig1s003,207223Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/14/2022 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206709s003;207223s003lbl.pdf
08/20/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206709s000,207223s000lbl.pdf
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