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OSP finalist
Action period
  1. Microbiology Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S...
    • ...MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE...
  2. Proprietary Name Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 PROPRIETARY NAME REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  3. Other Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057180rig15000 OTHER...
    • ...PMR/PMC Development Template This template should be completed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action...
  4. Pharmacology Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 PHARMACOLOGY REVIEW(S...
    • ...Ke Zhang, Ph.D. Pharmacologist Division of Gastroenterology and Inborn Errors Products David B. Joseph, Ph.D. Lead Pharmacologist Division...
  5. Statistical Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205718Orig1s000 STATISTICAL REVIEW(S...
    • ...Statistical Team Leader Memorandum Submission: NDA 205718/000 Product: AKYNZEOTM Netupitant 300 mg and Palonosetron 0.5 mg Fixed-Dose Combination (FDC...
  6. Summary Review

    Action date:
    FDA Application:
    NDA205718
    Drug:
    Akynzeo
    Active Ingredients:
    Netupitant; palonosetron hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2057180rig13000 SUMMARY REVIEW...
    • ...Division Director Review Division Director Review Date (electronic stamp) From Donna Griebel, MD Subject Division Director Slunmaiy...
  7. Letter

    Action date:
    FDA Application:
    NDA205713
    Drug:
    Oxygen, usp
    Active Ingredients:
    Oxygen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205713 NADA 141357 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205713 NADA 141357 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  8. Letter

    Action date:
    FDA Application:
    NDA205712
    Drug:
    Oxygen, usp
    Active Ingredients:
    Oxygen
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205712 NADA 141354 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205712 NADA 141354 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  9. Letter

    Action date:
    FDA Application:
    NDA205704
    Drug:
    Nitrious oxide, usp
    Active Ingredients:
    Nitrious oxide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205704 NADA 141350 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 205704 NADA 141350 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  10. Letter

    Action date:
    FDA Application:
    NDA205703
    Drug:
    Esmolol hydrochloride double strength in plastic container
    Active Ingredients:
    Esmolol hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205703 TENTATIVE APPROVAL HQ Specialty Pharma...
    • ...NDA 205703 Page 2 Section 505(c)(3)(C) of the Act provides that approval of a new drug application submitted pursuant to section 505(b)(2...