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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA208159
    Drug:
    Vistogard
    Active Ingredients:
    Uridine triacetate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208159/S-01 SUPPLEMENT APPROVAL Wellstat...
    • ...NDA 208159/S-01 Page 2 REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80...
  2. Label

    Action date:
    FDA Application:
    NDA208159
    Drug:
    Vistogard
    Active Ingredients:
    Uridine triacetate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VISTOGARD safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE VISTOGARD® is indicated for the emergency treatment of adult and pediatric patients...
  3. Letter

    Action date:
    FDA Application:
    NDA208159
    Drug:
    Vistogard
    Active Ingredients:
    Uridine triacetate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208159 NDA APPROVAL Wellstat Therapeutics Attention...
    • ...NDA 208159 Page 2 WAIVER OF HIGHLIGHTS SECTION We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights...
  4. Label

    Action date:
    FDA Application:
    NDA208147
    Drug:
    Dyanavel xr
    Active Ingredients:
    Amphetamine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DYANAVEL™ XR safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ABUSE AND DEPENDENCE CNS stimulants, including DYANAVEL XR, other amphetamine-containing products...
  5. Letter

    Action date:
    FDA Application:
    NDA208147
    Drug:
    Dyanavel xr
    Active Ingredients:
    Amphetamine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208147 NDA APPROVAL Tris Pharma Attention: Yulia...
    • ...NDA 208147 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...
  6. Summary Review

    Action date:
    FDA Application:
    NDA208147
    Drug:
    Dyanavel xr
    Active Ingredients:
    Amphetamine
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208147 SUMMARY REVIEW...
    • ...MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH...
  7. Label

    Action date:
    FDA Application:
    NDA208143
    Drug:
    Readi-cat 2
    Active Ingredients:
    Barium sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use READI-CAT 2 and READI-CAT 2 SMOOTHIE products...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 1 2 3 4 5 INDICATIONS AND USAGE DOSAGE AND ADMINISTRATION DOSAGE FORMS AND STRENGTHS CONTRAINDICATIONS...
  8. Letter

    Action date:
    FDA Application:
    NDA208143
    Drug:
    Readi-cat 2
    Active Ingredients:
    Barium sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208143 NDA APPROVAL Bracco Diagnostics Inc. Attention...
    • ...NDA 208143 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...
  9. Label

    Action date:
    FDA Application:
    NDA208135
    Drug:
    Tetracaine hydrochloride
    Active Ingredients:
    Tetracaine hydrochloride
    • ...NDA 208135 Page 4 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Tetracaine Hydrochloride...
    • ...NDA 208135 Page 5 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated...
  10. Letter

    Action date:
    FDA Application:
    NDA208135
    Drug:
    Tetracaine hydrochloride
    Active Ingredients:
    Tetracaine hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208135 NDA APPROVAL Alcon Research, Ltd. Attention...
    • ...NDA 208135 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...