Disclaimer: This is an early beta prototype. If you find any error, with data or functionality, please let us know via this page.
OSP finalist
Action period
  1. Medical Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...'5 l? ?3...
    • ...CLINICAL REVIEW Application Type P Application Number(s) NDA 205677 Priority or Standard Priority Submit Date(s) May 31, 2013 Received Date(s) May 31...
  2. Microbiology/Virology Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 MICROBIOLOGY / VIROLOGY REVIEW(S...
    • ...MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH DATE...
  3. Proprietary Name Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 PROPRIETARY NAME REVIEW(S...
    • ...Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office...
  4. Other Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ......
    • ...Selected Requirements of Prescribing Information is the numerical identi?er in parenthesis at the end of each summarized statement or topic. Comment...
  5. Pharmacology Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 PHARMACOLOGY REVIEW(S...
    • ...Tertiary Pharmacology Review By: Paul C. Brown, Ph.D., ODE Associate Director for Pharmacology and Toxicology, OND IO NDA: 205677 Submission date: 5...
  6. Statistical Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 205677Orig1s000 STATISTICAL REVIEW(S...
    • ...U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Office of Translational Sciences...
  7. Summary Review

    Action date:
    FDA Application:
    NDA205677
    Drug:
    Hetlioz
    Active Ingredients:
    Tasimelteon
    • ......
    • ...Division Director Review Summary Review for Regulatory Action...
  8. Label

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LACTIC ACIDOSIS 1 INDICATIONS AND USAGE 1.1 Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1...
  9. Letter

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 205649/S-005 SUPPLEMENT APPROVAL AstraZeneca...
    • ...NDA 205649/S-005 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content...
  10. Label

    Action date:
    FDA Application:
    NDA205649
    Drug:
    Xigduo xr
    Active Ingredients:
    Dapagliflozin propanediol; metformin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XIGDUO XR safely and effectively. See full...
    • ...2.1 Recommended Dosing 2.2 Patients with Renal Impairment 2.3 Discontinuation for Iodinated Contrast Imaging Procedures 3 DOSAGE FORMS AND STRENGTHS 4...