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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA205766
    Drug:
    Nitrogen, nf
    Active Ingredients:
    Nitrogen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205766 NADA 141364 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205766 NADA 141364 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  2. Letter

    Action date:
    FDA Application:
    NDA205765
    Drug:
    Medical air, usp
    Active Ingredients:
    Medical air
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205765 NADA 141363 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205765 NADA 141363 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  3. Letter

    Action date:
    FDA Application:
    NDA205764
    Drug:
    Carbon dioxide, usp
    Active Ingredients:
    Carbon dioxide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205764 NADA 141362 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205764 NADA 141362 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  4. Label

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK...
  5. Letter

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205755/S-003 NDA 205755/S-004 SUPPLEMENT APPROVAL...
    • ...NDA 205755/S-003 NDA 205755/S-004 Page 2 APPROVAL & LABELING We have completed our review of these supplemental applications, as amended...
  6. Label

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZYKADIA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ZYKADIA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK...
  7. Letter

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205755/S-003 NDA 205755/S-004 SUPPLEMENT APPROVAL...
    • ...NDA 205755/S-003 NDA 205755/S-004 Page 2 APPROVAL & LABELING We have completed our review of these supplemental applications, as amended...
  8. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...EXCLUSIVITY SUMMARY NDA # 205755 SUPPL # HFD # Trade Name Zykadia Generic Name ceritinib Applicant Name Novartis Pharmaceuticals Corporation...
  9. Risk Assessment and Risk Mitigation Review

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205755Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  10. Approval Letter

    Action date:
    FDA Application:
    NDA205755
    Drug:
    Zykadia
    Active Ingredients:
    Ceritinib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205755Orig1s000 Trade Name: Zykadia capsules, 150 mg Generic Name...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205755Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...