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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA208069
    Drug:
    Nitrous oxide, usp
    Active Ingredients:
    Nitrous oxide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208069 NADA 141446 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 208069 NADA 141446 Page 2 If you have any questions, please contact Michael Folkendt at (301) 796-1670 or by email at michael.folkendt...
  2. Label

    Action date:
    FDA Application:
    NDA208065
    Drug:
    Tagrisso
    Active Ingredients:
    Osimertinib mesylate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor...
  3. Letter

    Action date:
    FDA Application:
    NDA208065
    Drug:
    Tagrisso
    Active Ingredients:
    Osimertinib mesylate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208065/S-02 SUPPLEMENT APPROVAL AstraZeneca...
    • ...NDA 208065/S-02 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content...
  4. Label

    Action date:
    FDA Application:
    NDA208065
    Drug:
    Tagrisso
    Active Ingredients:
    Osimertinib mesylate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TAGRISSO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE TAGRISSO is indicated for the treatment of patients with metastatic epidermal growth factor...
  5. Letter

    Action date:
    FDA Application:
    NDA208065
    Drug:
    Tagrisso
    Active Ingredients:
    Osimertinib mesylate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208065 ACCELERATED APPROVAL AstraZeneca...
    • ...NDA 208065 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling...
  6. Summary Review

    Action date:
    FDA Application:
    NDA208065
    Drug:
    Tagrisso
    Active Ingredients:
    Osimertinib mesylate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2080650rig15000 SUMMARY REVIEW...
    • ...Division Director Summary Review Date November 10, 2015 From Patricia Keegan Subject Division Director Summaiy Review...
  7. Label

    Action date:
    FDA Application:
    NDA208056
    Drug:
    Dexilant solutab
    Active Ingredients:
    Dexlansoprazole
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXILANT safely and effectively. See full...
    • ...Page 2 of 31 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Healing of Erosive Esophagitis 1.2 Maintenance of Healed Erosive...
  8. Letter

    Action date:
    FDA Application:
    NDA208056
    Drug:
    Dexilant solutab
    Active Ingredients:
    Dexlansoprazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 22287/S-021/S-022/S-023 NDA 208056/S-01 SUPPLEMENT...
    • ...NDA 22287/S-021/S-022/S-023 NDA 208056/S-01 Page 2 APPROVAL & LABELING We have completed our review of these supplemental applications, as amended...
  9. Label

    Action date:
    FDA Application:
    NDA208056
    Drug:
    Dexilant solutab
    Active Ingredients:
    Dexlansoprazole
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DEXILANT safely and effectively. See full...
    • ...Page 2 of 28 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Healing of Erosive Esophagitis 1.2 Maintenance of Healed Erosive...
  10. Letter

    Action date:
    FDA Application:
    NDA208056
    Drug:
    Dexilant solutab
    Active Ingredients:
    Dexlansoprazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208056/Original 1 NDA APPROVAL Takeda Development...
    • ...NDA 208056/Original 1 Page 2 Section 7 Drug Interactions, Table 4 3. Underline the antiretrovirals in the “Intervention” row (i.e., Rilpivirine...