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. Letter

    Action date:
    FDA Application:
    NDA208026
    Drug:
    Jentadueto xr
    Active Ingredients:
    Linagliptin; metformin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208026 NDA APPROVAL Boehringer Ingelheim...
    • ...NDA 208026 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...
  2. Letter

    Action date:
    FDA Application:
    NDA208025
    Drug:
    Lansoprazole
    Active Ingredients:
    Lansoprazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208025 NDA APPROVAL Dexcel Pharma Technologies Ltd. c...
    • ...NDA 208025 Page 2 LABELING Submit final printed labeling (FPL), with the revisions listed above, as soon as they are available, but no more than 30...
  3. Label

    Action date:
    FDA Application:
    NDA208019
    Drug:
    Potassium chloride
    Active Ingredients:
    Potassium chloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use POTASSIUM CHLORIDE safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without...
  4. Letter

    Action date:
    FDA Application:
    NDA208019
    Drug:
    Potassium chloride
    Active Ingredients:
    Potassium chloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208019 NDA APPROVAL Pharma Research Software...
    • ...NDA 208019 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...
  5. Summary Review

    Action date:
    FDA Application:
    NDA208019
    Drug:
    Potassium chloride
    Active Ingredients:
    Potassium chloride
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2080190rig15000 SUMMARY REVIEW...
    • ...DIVISION OF CARDIOVASCULAR AND RENAL PRODUCTS Divisional Memo NDA: 208019 Potassium chloride powder for oral solution. Sponsor: Pharma Research...
  6. Label

    Action date:
    FDA Application:
    NDA208010
    Drug:
    Rayaldee
    Active Ingredients:
    Calcifediol
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RAYALDEE safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE RAYALDEE is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism...
  7. Letter

    Action date:
    FDA Application:
    NDA208010
    Drug:
    Rayaldee
    Active Ingredients:
    Calcifediol
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208010 NDA APPROVAL OPKO Ireland Global Holdings Ltd...
    • ...NDA 208010 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...
  8. Label

    Action date:
    FDA Application:
    NDA207999
    Drug:
    Ocaliva
    Active Ingredients:
    Obeticholic acid
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use OCALIVA safely and effectively. See full...
    • ...Page 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE OCALIVA™ is indicated for the treatment of primary biliary cholangitis (PBC...
  9. Letter

    Action date:
    FDA Application:
    NDA207999
    Drug:
    Ocaliva
    Active Ingredients:
    Obeticholic acid
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207999 ACCELERATED APPROVAL Intercept Pharmaceuticals...
    • ...NDA 207999 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final...
  10. Summary Review

    Action date:
    FDA Application:
    NDA207999
    Drug:
    Ocaliva
    Active Ingredients:
    Obeticholic acid
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2079990rig1s000 SUMMARY REVIEW...
    • ...Division Director Review Summary Review for Regulatory Action Date (electronic stamp) From Dragos Roman. MD...