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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208271
    Drug:
    Relistor
    Active Ingredients:
    Methylnaltrexone bromide
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RELISTOR safely and effectively. See full...
    • ...14 CLINICAL STUDIES 14.1 Opioid-Induced Constipation in Adult Patients with Chronic Non- Cancer Pain 14.2 Opioid-Induced Constipation in Adult...
  2. Letter

    Action date:
    FDA Application:
    NDA208271
    Drug:
    Relistor
    Active Ingredients:
    Methylnaltrexone bromide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208271 NDA APPROVAL Salix Pharmaceuticals Attention...
    • ...NDA 208271 Page 2 and As, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL...
  3. Label

    Action date:
    FDA Application:
    NDA208261
    Drug:
    Zepatier
    Active Ingredients:
    Elbasvir; grazoprevir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEPATIER safely and effectively. See full...
    • ...16 14.4 Clinical Trial in Subjects with Genotype 1 HCV and Severe Renal Impairment including Subjects on Hemodialysis (CSURFER) 14.5 Clinical Trials...
  4. Letter

    Action date:
    FDA Application:
    NDA208261
    Drug:
    Zepatier
    Active Ingredients:
    Elbasvir; grazoprevir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208261 NDA APPROVAL Merck Sharp & Dohme Corp...
    • ...NDA 208261 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  5. Summary Review

    Action date:
    FDA Application:
    NDA208261
    Drug:
    Zepatier
    Active Ingredients:
    Elbasvir; grazoprevir
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2082610rig13000 SUMMARY REVIEW...
    • ...Division Director Summary Review for Regulatory Action Date May 28, 2015 From Jeffrey Mluray Subject...
  6. Label

    Action date:
    FDA Application:
    NDA208253
    Drug:
    Acticlate cap
    Active Ingredients:
    Doxycycline hyclate
    • ...• See Full Prescribing Information for additional indication specific dosage information and important administration instructions for ACTICLATE...
    • ...6 7 8 5.4 Potentaial for Microbial Overgrowth 5.5 Intracranial Hypertension 5.6 Delayed Skeletal Development 5.7 Antianabolic Action 5.8...
  7. Letter

    Action date:
    FDA Application:
    NDA208253
    Drug:
    Acticlate cap
    Active Ingredients:
    Doxycycline hyclate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208253 NDA APPROVAL Aqua Pharmaceuticals Attention...
    • ...NDA 208253 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...
  8. Label

    Action date:
    FDA Application:
    NDA208251
    Drug:
    Otovel
    Active Ingredients:
    Ciprofloxacin hydrochloride; fluocinolone acetonide
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OTOVEL safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE OTOVEL is indicated for the treatment of acute otitis media with tympanostomy tubes (AOMT...
  9. Letter

    Action date:
    FDA Application:
    NDA208251
    Drug:
    Otovel
    Active Ingredients:
    Ciprofloxacin hydrochloride; fluocinolone acetonide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208251/Original -1 NDA APPROVAL Laboratorios SALVAT...
    • ...NDA 208251-1 Page 2 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL will be accessible...
  10. Label

    Action date:
    FDA Application:
    NDA208246
    Drug:
    Xeljanz xr
    Active Ingredients:
    Tofacitinib citrate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XELJANZ/XELJANZ XR safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS INFECTIONS AND MALIGNANCY 1 INDICATIONS AND USAGE 1.1 Rheumatoid Arthritis 2 DOSAGE...