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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA205739
    Drug:
    Veltassa
    Active Ingredients:
    Patiromer sorbitex calcium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205739/S-001 SUPPLEMENT APPROVAL Relypsa, Inc...
    • ...NDA 205739/S-001 Page 2 APPROVAL & LABELING We have completed our review of this supplemental application. It is approved, effective on the date...
  2. Label

    Action date:
    FDA Application:
    NDA205739
    Drug:
    Veltassa
    Active Ingredients:
    Patiromer sorbitex calcium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VELTASSA™ safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: BINDING TO OTHER ORAL MEDICATIONS Veltassa binds to many orally administered medications, which could decrease...
  3. Letter

    Action date:
    FDA Application:
    NDA205739
    Drug:
    Veltassa
    Active Ingredients:
    Patiromer sorbitex calcium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205739 NDA APPROVAL Relypsa, Inc. Attention: Sarah...
    • ...NDA 205739 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  4. Letter

    Action date:
    FDA Application:
    NDA205738
    Drug:
    Nitrogen, nf
    Active Ingredients:
    Nitrogen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205738 NADA 141359 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205738 NADA 141359 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  5. Letter

    Action date:
    FDA Application:
    NDA205737
    Drug:
    Oxygen, usp
    Active Ingredients:
    Oxygen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205737 NADA 141358 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205737 NADA 141358 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  6. Label

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated...
  7. Letter

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205718/S-003 SUPPLEMENT APPROVAL FULFILLMENT...
    • ...NDA 205718/S-003 Page 2 The SPL will be accessible from publicly available labeling repositories. Also within 14 days, amend all pending supplemental...
  8. Label

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AKYNZEO® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AKYNZEO is indicated for the prevention of acute and delayed nausea and vomiting associated...
  9. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...EXCLUSIVITY SUMMARY FOR NDA 205718 Trade Name: AKYNZEO SUPPL # N/A Generic Name: Netupitant palonosetron fixed-combination capsule Applicant Name...
  10. Approval Letter

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205718Orig1s000 Trade Name: Akynzeo Generic Name: Netupitant...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205718Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...