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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208054
    Drug:
    Axumin
    Active Ingredients:
    Fluciclovine f-18
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AXUMIN safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Axumin is indicated for positron emission tomography (PET) in men with suspected prostate...
  2. Letter

    Action date:
    FDA Application:
    NDA208054
    Drug:
    Axumin
    Active Ingredients:
    Fluciclovine f-18
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208054 NDA APPROVAL Michelle Wilson, Ph.D. U.S. Agent...
    • ...NDA 208054 Page 2 Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (June 2008). Alternatively, you may...
  3. Summary Review

    Action date:
    FDA Application:
    NDA208054
    Drug:
    Axumin
    Active Ingredients:
    Fluciclovine f-18
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2080540rig15000 SUMMARY REVIEW...
    • ...Division Director Summary Review NDA 208054, Axumin (Fluciclovine 18) Libero Marzella MD, Division Director Summary Review for Regulatory Action...
  4. Label

    Action date:
    FDA Application:
    NDA208036
    Drug:
    E-z-hd
    Active Ingredients:
    Barium sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use E-Z-HD safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 1 2 3 4 5 INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS...
  5. Letter

    Action date:
    FDA Application:
    NDA208036
    Drug:
    E-z-hd
    Active Ingredients:
    Barium sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208036 NDA APPROVAL Bracco Diagnostics Inc. Attention...
    • ...NDA 208036 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...
  6. Label

    Action date:
    FDA Application:
    NDA208032
    Drug:
    Kovanaze
    Active Ingredients:
    Oxymetazoline hydrochloride; tetracaine hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KOVANAZETM NASAL SPRAY safely and effectively...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE KOVANAZETM is indicated for regional anesthesia when performing a restorative procedure...
  7. Letter

    Action date:
    FDA Application:
    NDA208032
    Drug:
    Kovanaze
    Active Ingredients:
    Oxymetazoline hydrochloride; tetracaine hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208032 NDA APPROVAL St. Renatus, LLC 1000 Centre Ave...
    • ...NDA 208032 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:
    NDA208030
    Drug:
    Ferriprox
    Active Ingredients:
    Deferiprone
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208030 ACCELERATED APPROVAL ApoPharma Inc. c/o Cato...
    • ...NDA 208030 Page 2 of labeling must be identical to the enclosed labeling (text for the package insert and Medication Guide). Information...
  9. Summary Review

    Action date:
    FDA Application:
    NDA208030
    Drug:
    Ferriprox
    Active Ingredients:
    Deferiprone
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2080300rig15000 SUMMARY REVIEW...
    • ...Deputy Division Director Summary Review for Regulat01y Action...
  10. Label

    Action date:
    FDA Application:
    NDA208026
    Drug:
    Jentadueto xr
    Active Ingredients:
    Linagliptin; metformin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use JENTADUETO XR safely and effectively. See full...
    • ..._______________________________________________________________________________________________________________________________________ FULL...