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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA207953
    Drug:
    Yondelis
    Active Ingredients:
    Trabectedin
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207953/S-001 SUPPLEMENT APPROVAL/ FULLFILLMENT...
    • ...NDA 207953/S-001 Page 2 Information on submitting SPL files using eList may be found in the guidance for industry titled “SPL Standard for Content...
  2. Label

    Action date:
    FDA Application:
    NDA207953
    Drug:
    Yondelis
    Active Ingredients:
    Trabectedin
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use YONDELIS® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE YONDELIS® is indicated for the treatment of patients with unresectable or metastatic liposarcoma...
  3. Letter

    Action date:
    FDA Application:
    NDA207953
    Drug:
    Yondelis
    Active Ingredients:
    Trabectedin
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207953 NDA APPROVAL Janssen Products, L.P...
    • ...NDA 207953 Page 2 We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use...
  4. Summary Review

    Action date:
    FDA Application:
    NDA207953
    Drug:
    Yondelis
    Active Ingredients:
    Trabectedin
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICA TION NUMBER: 207 9530rig15000 SUMMARY REVIEW...
    • ...Division Director Summary Review Date From Sub ect NDA licant Name Date of Submission Ma or Amendment Received PDUFA Goal Date Proprietary Name...
  5. Letter

    Action date:
    FDA Application:
    NDA207949
    Drug:
    Cabazitaxel
    Active Ingredients:
    Cabazitaxel
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207949 TENTATIVE APPROVAL Accord Healthcare Inc...
    • ...NDA 207949 Page 2 This action must be taken prior to the expiration of forty-five days from the date the notice provided under section 505(b)(3...
  6. Label

    Action date:
    FDA Application:
    NDA207947
    Drug:
    Uptravi
    Active Ingredients:
    Selexipag
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UPTRAVI® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Pulmonary Arterial Hypertension UPTRAVI is indicated for the treatment of pulmonary...
  7. Letter

    Action date:
    FDA Application:
    NDA207947
    Drug:
    Uptravi
    Active Ingredients:
    Selexipag
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207947 NDA APPROVAL Actelion Pharmaceuticals, Ltd. c...
    • ...NDA 207947 Page 2 carton and immediate container labels, as soon as they are available, but no more than 30 days after they are printed. Please...
  8. Summary Review

    Action date:
    FDA Application:
    NDA207947
    Drug:
    Uptravi
    Active Ingredients:
    Selexipag
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 947 SUMMARY REVIEW...
    • ...DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS Divisional Memo Addendum NDA: 207947 UPTRAVI (selexipag for PAH. Sponsor: Actelion Review date: 18...
  9. Label

    Action date:
    FDA Application:
    NDA207946
    Drug:
    Invega trinza
    Active Ingredients:
    Paliperidone palmitate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use INVEGA TRINZA® safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 1  INDICATIONS AND USAGE  2...
  10. Letter

    Action date:
    FDA Application:
    NDA207946
    Drug:
    Invega trinza
    Active Ingredients:
    Paliperidone palmitate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 021346 S-055 NDA 022264 S-019 NDA 020272 S-077 NDA...
    • ...NDA 021346 S-055 NDA 022264 S-019 NDA 020272 S-077 NDA 021444 S-051 NDA 020588 S-065 NDA 021999 S-030 NDA 207946 S-001 Page 2 APPROVAL & LABELING We...