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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...Reference ID: 3779955 HFA {mmiasmefuroate} 100 mcgper actuation Fur oral inhalatio l'l Dnlj' UsemlywiilmmanexHFA canisters...
    • ...Reference ID: 3779955 I 'uaiplnp 10 meal in ma daax lieu-29} BJHIEJiidlual mom panama: 19 31015 :0 Mu Asmanex...
  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/S-002 SUPPLEMENT APPROVAL Merck Sharp...
    • ...NDA 205641/S-002 Page 2 PROMOTIONAL MATERIALS You may request advisory comments on proposed introductory advertising and promotional labeling. To do...
  3. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...Department of Health and Human Services Food and Drug Administration PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER OF AN NDA, AMENDMENT...
  4. Risk Assessment and Risk Mitigation Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 RISK ASSESSMENT and RISK MITIGATION REVIEW(S...
    • ...Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology...
  5. Approval Letter

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205641Orig1s000 Trade Name: Asmanex HFA 100 mcg and 200 mcg...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205641Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...
  6. Clinical Pharmacology Biopharmaceutics Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S...
    • ...OFFICE OF CLINICAL PHARMACOLOGY: CLINICAL PHARMACOLOGY REVIEW NDA 205641 Submission Date: June 26, 2013 Brand Name: Asmanex® HFA Generic Name...
  7. Chemistry 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 CHEMISTRY...
    • ...DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 NDA 205-641 CR01 Addendum 01 Date...
  8. Cross Discipline Team Leader Review

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 CROSS DISCIPLINE TEAM LEADER REVIEW...
    • ...Cross Discipline Team Leader Review NDA 205641. Asmanex HFA (mometasone furoate inhalation aerosol) Anthony G. Dunnowicz. M.D. Cross-Discipline...
  9. Officer/Employee List

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205641Orig1s000 OFFICER/EMPLOYEE LIST...
    • ...Of?cer/Employee List Application: NDA 205641 The following of?cers or employees of FDA participated in the decision to approve this application...
  10. Label

    Action date:
    FDA Application:
    NDA205641
    Drug:
    Asmanex hfa
    Active Ingredients:
    Mometasone furoate
    • ... HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ASMANEX HFA safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Treatment of Asthma ASMANEX® HFA is indicated for the maintenance treatment of asthma...