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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208114
    Drug:
    Defitelio
    Active Ingredients:
    Defibrotide sodium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2081140rig15000 LABELING...
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEFITELIO safely and effectively. See full...
  2. Letter

    Action date:
    FDA Application:
    NDA208114
    Drug:
    Defitelio
    Active Ingredients:
    Defibrotide sodium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208114 NDA APPROVAL Gentium S.r.L. c/o Jazz...
    • ...NDA 208114 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed immediate container and carton labels that are identical...
  3. Summary Review

    Action date:
    FDA Application:
    NDA208114
    Drug:
    Defitelio
    Active Ingredients:
    Defibrotide sodium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2081140rig18000 SUMMARY REVIEW...
    • ...Division Director Summary Review for Regulatory Action Date (electronic stamp) From Ann. T. Farrell, M.D., Division Director...
  4. Letter

    Action date:
    FDA Application:
    NDA208109
    Drug:
    Palonosetron
    Active Ingredients:
    Palonosetron hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208109 TENTATIVE APPROVAL Fresenius Kabi USA, LLC...
    • ...NDA 208109 Page 2 manufacture, use, or sale of, this drug product under this application (“Paragraph IV certifications”). Section 505(c)(3)(C...
  5. Letter

    Action date:
    FDA Application:
    NDA208090
    Drug:
    Xtampza er
    Active Ingredients:
    Oxycodone
    • ....+>""'~"~ ( ..lff!._ •+,~~~ ~...(J DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA208090...
    • ...NDA 208090 Page 2 manufacture, use, or sale of, this drug product under this application (“Paragraph IV certifications”). Section 505(c)(3)(C...
  6. Label

    Action date:
    FDA Application:
    NDA208081
    Drug:
    Ameluz
    Active Ingredients:
    Aminolevulinic acid hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AMELUZ safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE AMELUZ® gel, in combination with photodynamic therapy (PDT) using BF-RhodoLED® lamp...
  7. Letter

    Action date:
    FDA Application:
    NDA208081
    Drug:
    Ameluz
    Active Ingredients:
    Aminolevulinic acid hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208081 NDA APPROVAL Biofrontera Bioscience GmbH c/o...
    • ...NDA 208081 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  8. Letter

    Action date:
    FDA Application:
    NDA208079
    Drug:
    Sernivo
    Active Ingredients:
    Betamethasone dipropionate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208079 NDA APPROVAL Promius Pharma, LLC Attention...
    • ...NDA 208079 Page 2 Submit final printed carton and immediate container labels that are identical to the enclosed carton and immediate container labels...
  9. Label

    Action date:
    FDA Application:
    NDA208073
    Drug:
    Xiidra
    Active Ingredients:
    Lifitegrast
    • ...NDA 208073 Page 5 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIIDRA safely...
    • ...NDA 208073 Page 6 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Xiidra™ (lifitegrast ophthalmic solution) 5% is indicated for the treatment...
  10. Letter

    Action date:
    FDA Application:
    NDA208073
    Drug:
    Xiidra
    Active Ingredients:
    Lifitegrast
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208073 NDA APPROVAL Shire Development LLC Attention...
    • ...NDA 208073 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...