Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209080
Company: ITALFARMACO SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIGLUTIK KIT RILUZOLE 50MG/10ML SUSPENSION;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
09/05/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209080s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209080Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209080Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209080s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209080Orig1s003ltr.pdf
12/13/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209080s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209080Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209080s003lbl.pdf
12/13/2019 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209080s001lbl.pdf
09/05/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209080s000lbl.pdf

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