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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BASAGLAR safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ® BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1...
  2. Letter

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205692/S-005 SUPPLEMENT APPROVAL Eli Lilly...
    • ...NDA 205692/S-005 Page 2 Also within 14 days, amend all pending supplemental applications that includes labeling changes for this NDA, including CBE...
  3. Label

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BASAGLAR safely and effectively. See full...
    • ...1 INDICATIONS AND USAGE ® BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus...
  4. Letter

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205692/S-001 SUPPLEMENT APPROVAL Eli Lilly...
    • ...NDA 205692/S-001 Page 2 http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf The SPL will be accessible...
  5. Label

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BASAGLAR safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ® BASAGLAR is indicated to improve glycemic control in adults and pediatric patients with type 1...
  6. Letter

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205692 NDA APPROVAL Eli Lilly and Company Attention...
    • ...NDA 205692 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...
  7. Summary Review

    Action date:
    FDA Application:
    NDA205692
    Drug:
    Basaglar
    Active Ingredients:
    Insulin glargine
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2056920rig15000 SUMMARY REVIEW...
    • ...Division Director Review Summary Review for Regulatory Action Date (electronic stamp) From Jean-Marc...
  8. Label

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HETLIOZ safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE HETLIOZ is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). 2 DOSAGE...
  9. Letter

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205677/S-001 SUPPLEMENT APPROVAL Vanda...
    • ...NDA 205677/S-001 Page 2 Information on submitting SPL files using eList may be found in the guidance for industry titled “SPL Standard for Content...
  10. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...EXCLUSIVITY SUMMARY NDA # 205677 SUPPL # HFD # Trade Name HETLIOZ Generic Name Tasimelteon, 20 mg Capsules Applicant Name Vanda Pharmaceuticals...