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OSP finalist
Action period
  1. Proprietary Name Review

    Action date:
    FDA Application:
    NDA205787
    Drug:
    Evzio
    Active Ingredients:
    Naloxone hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205787Orig1s000 PROPRIETARY NAME REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  2. Other Review

    Action date:
    FDA Application:
    NDA205787
    Drug:
    Evzio
    Active Ingredients:
    Naloxone hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 87 OTHER...
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES MEMORANDUM Food and Drug Administration Office of Device Evaluation 10903 New Hampshire Avenue Silver Spring...
  3. Pharmacology Review

    Action date:
    FDA Application:
    NDA205787
    Drug:
    Evzio
    Active Ingredients:
    Naloxone hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205787Orig1s000 PHARMACOLOGY REVIEW(S...
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH PHARMACOLOGY...
  4. Summary Review

    Action date:
    FDA Application:
    NDA205787
    Drug:
    Evzio
    Active Ingredients:
    Naloxone hydrochloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2057 87 SUMMARY REVIEW...
    • .... 5? q, 2 .. ?5 ?f FDA CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION OF ANESTHESIA, ANALGESIA, AND ADDICTION PRODUCTS Summary...
  5. Label

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment...
  6. Letter

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205786 S-3 NDA 203045 S-12 NDA 22145 S-35 SUPPLEMENT...
    • ...NDA 205786 S-3 NDA 203045 S-12 NDA 22145 S-35 Page 2 • To update the Patient Information section entitled, “What should I tell my doctor before...
  7. Label

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment...
  8. Letter

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205786 S-2 NDA 203045 S-11 NDA 22145 S-34 SUPPLEMENT...
    • ...NDA 205786 S-2 NDA 203045 S-11 NDA 22145 S-34 Page 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content...
  9. Label

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ISENTRESS safely and effectively. See full...
    • ...14.3 Pediatric Subjects 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 12.4 Microbiology 13 NONCLINICAL TOXICOLOGY 13.1...
  10. Letter

    Action date:
    FDA Application:
    NDA205786
    Drug:
    Isentress
    Active Ingredients:
    Raltegravir potassium
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA22145/S-032 NDA 203045/S-010 NDA 205786/S-01...
    • ...NDA22145/S-032 NDA 203045/S-010 NDA 205786/S-01 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date...