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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TECHNIVIE safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TECHNIVIE is indicated in combination with ribavirin for the treatment of patients with genotype...
  2. Letter

    Action date:
    FDA Application:
    NDA207931
    Drug:
    Technivie
    Active Ingredients:
    Ombitasvir; paritaprevir; ritonavir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207931 NDA APPROVAL AbbVie Inc. Attention: Glen W...
    • ...NDA 207931 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  3. Label

    Action date:
    FDA Application:
    NDA207930
    Drug:
    Utibron
    Active Ingredients:
    Glycopyrrolate ; indacaterol maleate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use UTIBRON NEOHALER safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION WARNING: ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABAs) increase the risk of asthma-related death...
  4. Letter

    Action date:
    FDA Application:
    NDA207930
    Drug:
    Utibron
    Active Ingredients:
    Glycopyrrolate ; indacaterol maleate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207930 NDA APPROVAL Novartis Pharmaceuticals...
    • ...NDA 207930 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  5. Summary Review

    Action date:
    FDA Application:
    NDA207930
    Drug:
    Utibron
    Active Ingredients:
    Glycopyrrolate ; indacaterol maleate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 9300rig15000 SUMMARY REVIEW...
    • ...SUMMARY REVIEW OF REGULATORY ACTION Date: October 29, 2015 From: Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary, Allergy...
  6. Label

    Action date:
    FDA Application:
    NDA207926
    Drug:
    Phenylephrine hydrochloride
    Active Ingredients:
    Phenylephrine hydrochloride
    • ...NDA 207926 Page 4 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PHENYLEPHRINE...
    • ...NDA 207926 Page 5 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Phenylephrine Hydrochloride Ophthalmic Solution, USP 2.5% and 10...
  7. Letter

    Action date:
    FDA Application:
    NDA207926
    Drug:
    Phenylephrine hydrochloride
    Active Ingredients:
    Phenylephrine hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207926 NDA APPROVAL Akorn, Inc. Attention: Sam...
    • ...NDA 207926 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via...
  8. Label

    Action date:
    FDA Application:
    NDA207925
    Drug:
    Kalydeco
    Active Ingredients:
    Ivacaftor
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KALYDECO safely and effectively. See full...
    • ...KALYDECO® (ivacaftor) Tablets and Granules FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE KALYDECO is a cystic fibrosis transmembrane...
  9. Letter

    Action date:
    FDA Application:
    NDA207925
    Drug:
    Kalydeco
    Active Ingredients:
    Ivacaftor
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207925 NDA APPROVAL Vertex Pharmaceuticals 50...
    • ...NDA 207925 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible via...
  10. Summary Review

    Action date:
    FDA Application:
    NDA207925
    Drug:
    Kalydeco
    Active Ingredients:
    Ivacaftor
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 9250rig15000 SUMMARY REVIEW...
    • ...SUMMARY REVIEW OF REGULATORY ACTION Date: March 17, 2015 From: Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary, Allergy...