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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208854
Company: BDSI

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYMPROIC NALDEMEDINE TOSYLATE EQ 0.2MG BASE 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
03/23/2017 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208854Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208854Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/24/2018 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208854Orig1s002ltr.pdf
08/01/2017 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208854Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/24/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf
01/24/2018 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf
01/24/2018 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208854s002lbl.pdf
08/01/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s001lbl.pdf
08/01/2017 SUPPL-1 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s001lbl.pdf
03/23/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208854s000lbl.pdf
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