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OSP finalist
Action period
  1. 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-004 SUPPLEMENT APPROVAL BioDelivery Science...
    • ...NDA 205637/S-004 Page 2 Your proposed modification to the BTOD REMS, including appended REMS materials as applicable, consists of the following...
  2. Label

    Action date:
    FDA Application:
    NDA205636
    Drug:
    Proair respiclick
    Active Ingredients:
    Albuterol sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Bronchospasm PROAIR RESPICLICK (albuterol sulfate) inhalation powder is indicated...
  3. Letter

    Action date:
    FDA Application:
    NDA205636
    Drug:
    Proair respiclick
    Active Ingredients:
    Albuterol sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205636/S-004 SUPPLEMENT APPROVAL FULFILLMENT...
    • ...NDA 205636/S-004 Page 2 http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf The SPL will be accessible...
  4. Label

    Action date:
    FDA Application:
    NDA205636
    Drug:
    Proair respiclick
    Active Ingredients:
    Albuterol sulfate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROAIR RESPICLICK safely and effectively. See...
    • ...1 INDICATIONS AND USAGE 1.1 Bronchospasm PROAIR RESPICLICK (albuterol sulfate) inhalation powder is indicated for the treatment or prevention...
  5. Letter

    Action date:
    FDA Application:
    NDA205636
    Drug:
    Proair respiclick
    Active Ingredients:
    Albuterol sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205636 NDA APPROVAL Teva Pharmaceutical Products R...
    • ...NDA 205636 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via...
  6. Summary Review

    Action date:
    FDA Application:
    NDA205636
    Drug:
    Proair respiclick
    Active Ingredients:
    Albuterol sulfate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2056360rig1s000 SUMMARY REVIEW...
    • ...SUMMARY REVIEW OF REGULATORY ACTION Date: March 31, 2015 From: Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary, Allergy...
  7. Label

    Action date:
    FDA Application:
    NDA205625
    Drug:
    Arnuity ellipta
    Active Ingredients:
    Fluticasone furoate
    • ....?arh blls?vr 20") mm: of fm 1.1T .md 2.1m p90 Dosage: L'sv onlx your (imtnr. IMPORTANT: mv I?am'n? Infor-nn?lor?. (awfully fur fudlwr 'nforrn.m(m...
    • ...(fluticasone furoate inhalation powder) See prescribing infonnation for dosage information. Store at room temperature between and and excursions...
  8. Letter

    Action date:
    FDA Application:
    NDA205625
    Drug:
    Arnuity ellipta
    Active Ingredients:
    Fluticasone furoate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205625/S-001 SUPPLEMENT APPROVAL GlaxoSmithKline...
    • ...NDA 205625/S-001 Page 2 REQUIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new...
  9. Label

    Action date:
    FDA Application:
    NDA205625
    Drug:
    Arnuity ellipta
    Active Ingredients:
    Fluticasone furoate
    • ...• Immunosuppression: Potential worsening of existing tuberculosis, fungal, bacterial, viral, parasitic infections or ocular herpes simplex. Use...
    • ...FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE 1.1 Treatment of Asthma ARNUITY™ ELLIPTA® is indicated for the once-daily maintenance treatment...
  10. Letter

    Action date:
    FDA Application:
    NDA205625
    Drug:
    Arnuity ellipta
    Active Ingredients:
    Fluticasone furoate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205625 NDA APPROVAL GlaxoSmithKline Five Moore Drive...
    • ...NDA 205625 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...