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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA207318
    Drug:
    Nuplazid
    Active Ingredients:
    Pimavanserin tartrate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207318 NDA APPROVAL ACADIA Pharmaceuticals Inc...
    • ...NDA 207318 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your...
  2. Summary Review

    Action date:
    FDA Application:
    NDA207318
    Drug:
    Nuplazid
    Active Ingredients:
    Pimavanserin tartrate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 3180rig18000 SUMMARY REVIEW...
    • ...A DEPARTMENT OF HEALTH AND HUIVIAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH...
  3. Label

    Action date:
    FDA Application:
    NDA207233
    Drug:
    Vivlodex
    Active Ingredients:
    Meloxicam
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full...
    • ...INITIAL U.S. APPROVAL: 2000  8.2   Lactation  WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS  8.3   Females and Males...
  4. Letter

    Action date:
    FDA Application:
    NDA207233
    Drug:
    Vivlodex
    Active Ingredients:
    Meloxicam
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207233 NDA APPROVAL Iroko Pharmaceuticals LLC One Kew...
    • ...NDA 207233 Page 2 industry SPL Standard for Content of Labeling Technical Qs and As, available at http://www.fda.gov/downloads/Drugs...
  5. Label

    Action date:
    FDA Application:
    NDA207174
    Drug:
    Paricalcitol
    Active Ingredients:
    Paricalcitol
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PARICALCITOL INJECTION safely and effectively...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Paricalcitol Injection is an active vitamin D2 analogue indicated for the prevention...
  6. Letter

    Action date:
    FDA Application:
    NDA207174
    Drug:
    Paricalcitol
    Active Ingredients:
    Paricalcitol
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207174 NDA APPROVAL Accord Healthcare Inc. Attention...
    • ...NDA 207174 Page 2 Content of labeling must be identical to the enclosed labeling (text for the package insert, text for the patient package insert...
  7. Letter

    Action date:
    FDA Application:
    NDA207166
    Drug:
    Carbon dioxide, usp
    Active Ingredients:
    Carbon dioxide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207166 DEEMED GRANTED MEDICAL GAS CERTIFICATION...
    • ...NDA 207166 Page 2 If you have any questions, please contact Michael Folkendt at (301) 796-1670 or by email at [email protected] Sincerely...
  8. Label

    Action date:
    FDA Application:
    NDA207155
    Drug:
    Evomela
    Active Ingredients:
    Melphalan hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use EVOMELA safely and effectively. See full...
    • ...1 FULL PRESCRIBING INFORMATION WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY, and LEUKEMOGENICITY • Severe bone marrow suppression...
  9. Letter

    Action date:
    FDA Application:
    NDA207155
    Drug:
    Evomela
    Active Ingredients:
    Melphalan hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207155/ Original 1 NDA 207155/ Original 2 NDA...
    • ...NDA 207155/ Original 1 NDA 207155/ Original 2 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter...
  10. Label

    Action date:
    FDA Application:
    NDA207154
    Drug:
    Aczone
    Active Ingredients:
    Dapsone
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACZONE® Gel, 7.5% safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ACZONE® (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients...