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OSP finalist
Action period
  1. Printed Labeling

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2056410rig13000 LABELING...
    • ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See...
  2. Letter

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205641 NDA APPROVAL Merck Sharp & Dohme Corp. One...
    • ...NDA 205641 Page 2 As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l...
  3. Medical Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2056410rig15000 MEDICAL...
    • ...CLINICAL REVIEW Application Type Application Number(s) Priority or Standard Submit Date(s) Received Date(s) PDUFA Goal Date Division / Office NDA...
  4. Microbiology Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 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...
  5. Proprietary Name Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 PROPRIETARY NAME REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  6. Other Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2056410rig15000 OTHER...
    • ...Clinical Investigator Financial Disclosure Review Template Application Number: 205-641 Submission Date(s): June 27, 2013 Applicant: Merck Product...
  7. Pharmacology Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 PHARMACOLOGY REVIEW(S...
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PHARMACOLOGY...
  8. Statistical Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 STATISTICAL REVIEW(S...
    • ...U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Translational Science...
  9. Summary Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2056410rig13000 SUMMARY REVIEW...
    • ...Summary Review of Regulatory Action Date April 25, 2014 From Lydia I. Gilbert-McClain, MD Subject Summary Review of regulatory action NDA NDA...
  10. Letter

    Action date:
    FDA Application:
    NDA205637
    Drug:
    Bunavail
    Active Ingredients:
    Buprenorphine hydrochloride; naloxone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205637/S-009 SUPPLEMENT APPROVAL Biodelivery...
    • ...NDA 205637/S-009 Page 2 • the Appropriate Use Checklist • the Dear Prescriber Letter • the Dear Pharmacist Letter Your proposed modified REMS...