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OSP finalist
Action period
  1. Summary Review

    Action date:
    FDA Application:
    NDA205625
    Drug:
    Arnuity ellipta
    Active Ingredients:
    Fluticasone furoate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2056250rig15000 SUMMARY REVIEW...
    • ...SUMMARY REVIEW OF REGULATORY ACTION Date: August 20, 2014 From: Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary, Allergy...
  2. Label

    Action date:
    FDA Application:
    NDA205613
    Drug:
    Uceris
    Active Ingredients:
    Budesonide
    • ...• HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UCERIS rectal foam safely and effectively...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE UCERIS rectal foam is indicated for the induction of remission in patients with active mild...
  3. Letter

    Action date:
    FDA Application:
    NDA205613
    Drug:
    Uceris
    Active Ingredients:
    Budesonide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205613 NDA APPROVAL Salix Pharmaceuticals, Inc...
    • ...NDA 205613 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your...
  4. Summary Review

    Action date:
    FDA Application:
    NDA205613
    Drug:
    Uceris
    Active Ingredients:
    Budesonide
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2056130rig15000 SUMMARY REVIEW...
    • ...Deputy Division Director Review NBA 2056] 3 Uceris (budesonide) rectal foam 2 mg September 15, 2014 Summary Review for Regulatory Action...
  5. Label

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...• Noxafil oral suspension 40 mg per mL (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 1 2 3 4 5 6 7 INDICATIONS AND USAGE 1.1 Prophylaxis of Invasive Aspergillus and Candida Infections 1.2...
  6. Letter

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022003/S-018, S-020 NDA 205053/S-002, S-004 NDA...
    • ...NDA 022003/S-018, S-020 NDA 205053/S-002, S-004 NDA 205596/S-001, S-003 Page 2 added and separate tables for compatible diluents and compatible drugs...
  7. Label

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...• Noxafil oral suspension 40 mg per mL (3) HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* 1 2 3 4 5 6 7 INDICATIONS AND USAGE 1.1 Prophylaxis of Invasive Aspergillus and Candida Infections 1.2...
  8. Letter

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022003/S-018, S-020 NDA 205053/S-002, S-004 NDA...
    • ...NDA 022003/S-018, S-020 NDA 205053/S-002, S-004 NDA 205596/S-001, S-003 Page 2 added and separate tables for compatible diluents and compatible drugs...
  9. Administrative Document & Correspondence

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205596Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS...
    • ...EXCLUSIVITY SUMMARY NDA # 205596 SUPPL # HFD # Trade Name Noxafil Injection, 18 mg/mL Generic Name Posaconazole Applicant Name Merck Sharp & Dohme...
  10. Approval Letter

    Action date:
    FDA Application:
    NDA205596
    Drug:
    Noxafil
    Active Ingredients:
    Posaconazole
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 205596Orig1s000 Trade Name: Noxafil Generic Name: Posaconazole...
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH 205596Orig1s000 CONTENTS Reviews / Information Included in this NDA Review. Approval Letter Other Action...