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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA207154
    Drug:
    Aczone
    Active Ingredients:
    Dapsone
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207154 NDA APPROVAL Allergan, Inc. Attention: Jeremy...
    • ...NDA 207154 Page 2 available, but no more than 30 days after they are printed. Please submit these labels electronically according to the guidance...
  2. Label

    Action date:
    FDA Application:
    NDA207131
    Drug:
    Cefazolin in plastic container
    Active Ingredients:
    Cefazolin sodium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CEFAZOLIN injection safely and effectively...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Preoperative Prophylaxis Cefazolin injection is indicated for preoperative prophylaxis...
  3. Letter

    Action date:
    FDA Application:
    NDA207131
    Drug:
    Cefazolin in plastic container
    Active Ingredients:
    Cefazolin sodium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207131 NDA APPROVAL Celerity Pharmaceuticals, LLC...
    • ...NDA 207131 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:
    NDA207131
    Drug:
    Cefazolin in plastic container
    Active Ingredients:
    Cefazolin sodium
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2071310rig13000 SUMMARY REVIEW...
    • ...NDA 207131. Cefazolin injection. 2 gram Division Director Decisional Memo Date (electronic stamp) From...
  5. Letter

    Action date:
    FDA Application:
    NDA207114
    Drug:
    Medical gas, usp
    Active Ingredients:
    Medical gas
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207114 NADA 141432 DEEMED GRANTED MEDICAL GAS...
    • ...NDA 207114 NADA 141432 Page 2 Please include the NDA and NADA numbers listed above at the top of the first page of any such communications. If you...
  6. Label

    Action date:
    FDA Application:
    NDA207103
    Drug:
    Ibrance
    Active Ingredients:
    Palbociclib
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IBRANCE safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IBRANCE is indicated for the treatment of HR-positive, HER2-negative advanced or metastatic...
  7. Letter

    Action date:
    FDA Application:
    NDA207103
    Drug:
    Ibrance
    Active Ingredients:
    Palbociclib
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207103/S-002 SUPPLEMENT APPROVAL FULFILLMENT...
    • ...NDA 207103/S-002 Page 2 http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL...
  8. Label

    Action date:
    FDA Application:
    NDA207103
    Drug:
    Ibrance
    Active Ingredients:
    Palbociclib
    • ...----------------------- WARNINGS AND PRECAUTIONS ----------------------­ • Hematologic: Neutropenia may occur. Monitor complete blood count prior...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE IBRANCE is indicated in combination with letrozole for the treatment of postmenopausal women...
  9. Letter

    Action date:
    FDA Application:
    NDA207103
    Drug:
    Ibrance
    Active Ingredients:
    Palbociclib
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207103 ACCELERATED APPROVAL Pfizer Inc. Attention...
    • ...NDA 207103 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 [21...
  10. Summary Review

    Action date:
    FDA Application:
    NDA207103
    Drug:
    Ibrance
    Active Ingredients:
    Palbociclib
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2071030rig1s000 SUMMARY REVIEW...
    • ...Division Director Review NDA 207103. Palbociclib Summary Review for Regulatory Action Date 2/3 /201 5 From Amna Ibrahim...