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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA207988
    Drug:
    Zurampic
    Active Ingredients:
    Lesinurad
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZURAMPIC safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: RISK OF ACUTE RENAL FAILURE, MORE COMMON WHEN USED WITHOUT A XANTHINE OXIDASE INHIBITOR   Acute renal...
  2. Letter

    Action date:
    FDA Application:
    NDA207988
    Drug:
    Zurampic
    Active Ingredients:
    Lesinurad
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207988 NDA APPROVAL Ardea Biosciences, Inc. 9390...
    • ...NDA 207988 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  3. Summary Review

    Action date:
    FDA Application:
    NDA207988
    Drug:
    Zurampic
    Active Ingredients:
    Lesinurad
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2079880rig1s000 SUMMARY REVIEW...
    • ...SUMMARY REVIEW OF REGULATORY ACTION Date: November 23, 2015 From: Badrul A. Chowdhury, MD, PhD Director, Division of Pulmonary, Allergy...
  4. Label

    Action date:
    FDA Application:
    NDA207986
    Drug:
    Otiprio
    Active Ingredients:
    Ciprofloxacin
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTIPRIO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE OTIPRIO is indicated for the treatment of pediatric patients with bilateral otitis media...
  5. Letter

    Action date:
    FDA Application:
    NDA207986
    Drug:
    Otiprio
    Active Ingredients:
    Ciprofloxacin
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207986/S-001 SUPPLEMENT APPROVAL Otonomy, Inc...
    • ...--------------------------------------------------------------------------------------------------------This is a representation of an electronic...
  6. Label

    Action date:
    FDA Application:
    NDA207986
    Drug:
    Otiprio
    Active Ingredients:
    Ciprofloxacin
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTIPRIO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE OTIPRIO is indicated for the treatment of pediatric patients with bilateral otitis media...
  7. Letter

    Action date:
    FDA Application:
    NDA207986
    Drug:
    Otiprio
    Active Ingredients:
    Ciprofloxacin
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207986 NDA APPROVAL Otonomy, Inc. Attention: Barbara...
    • ...NDA 207986 Page 2 after they are printed. Please submit these labels electronically according to the guidance for industry Providing Regulatory...
  8. Summary Review

    Action date:
    FDA Application:
    NDA207986
    Drug:
    Otiprio
    Active Ingredients:
    Ciprofloxacin
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2079860rig1s000 SUMMARY REVIEW...
    • ...Division Director Memo; NDA 207986. Cipro?oxacin Otic Solution Division Director Memo Date (electronic stamp) From...
  9. Label

    Action date:
    FDA Application:
    NDA207981
    Drug:
    Lonsurf
    Active Ingredients:
    Tipiracil hydrochloride; trifluridine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LONSURF safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE LONSURF is indicated for the treatment of patients with metastatic colorectal cancer who have...
  10. Letter

    Action date:
    FDA Application:
    NDA207981
    Drug:
    Lonsurf
    Active Ingredients:
    Tipiracil hydrochloride; trifluridine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207981 NDA APPROVAL Taiho Oncology, Inc. Attention...
    • ...NDA 207981 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...