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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020599
Company: COVIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RILUTEK RILUZOLE 50MG TABLET;ORAL Prescription AB Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2020 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020599s019lbl.pdf
04/08/2016 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020599s017lbl.pdf
11/16/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s013lbl.pdf
07/10/2009 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf
07/10/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020599s011s012lbl.pdf
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