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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA207648
    Drug:
    Smoflipid 20%
    Active Ingredients:
    Fish oil; medium chain triglycerides; olive oil; soybean oil
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207648/Original 1 NDA APPROVAL Fresenius Kabi USA...
    • ...NDA 207648/Original1 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content...
  2. Label

    Action date:
    FDA Application:
    NDA207621
    Drug:
    Troxyca er
    Active Ingredients:
    Naltrexone hydrochloride; oxycodone hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMAT ION These highlights do not include all the inf ormation needed to use T ROXYCA E R saf ely an d ef f ectively. See...
    • ...FULL PRE S CRIBING INFORMAT ION: CONT E NT S * 7 8 DRUG INT ERACT IONS US E IN S PE CIFIC POPUL AT IONS 8.1 P regnancy 8.2 Lactation 8.3 F...
  3. Letter

    Action date:
    FDA Application:
    NDA207621
    Drug:
    Troxyca er
    Active Ingredients:
    Naltrexone hydrochloride; oxycodone hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993 NDA 207621 NDA APPROVAL Pfizer Inc. 500 Arcola Road...
    • ...NDA 207621 Page 2 industry SPL Standard for Content of Labeling Technical Qs and As, available at http://www.fda.gov/downloads/Drugs...
  4. Label

    Action date:
    FDA Application:
    NDA207620
    Drug:
    Entresto
    Active Ingredients:
    Sacubitril; valsartan
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) • Drugs that act...
  5. Letter

    Action date:
    FDA Application:
    NDA207620
    Drug:
    Entresto
    Active Ingredients:
    Sacubitril; valsartan
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207620 NDA APPROVAL Novartis Pharmaceuticals Corp...
    • ...NDA 207620 Page 2 of labeling must be identical to the enclosed labeling (text for the package insert and text for the patient package insert...
  6. Summary Review

    Action date:
    FDA Application:
    NDA207620
    Drug:
    Entresto
    Active Ingredients:
    Sacubitril; valsartan
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 6200rig15000 SUMMARY REVIEW...
    • ...Cross Discipline Team Leader Review Cross-Discipline Team Leader Review Date J1me 12. 2015 From Aliza Thompson...
  7. Label

    Action date:
    FDA Application:
    NDA207589
    Drug:
    Enstilar
    Active Ingredients:
    Betamethasone dipropionate; calcipotriene
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENSTILAR® Foam safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical...
  8. Letter

    Action date:
    FDA Application:
    NDA207589
    Drug:
    Enstilar
    Active Ingredients:
    Betamethasone dipropionate; calcipotriene
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207589/S-001 SUPPLEMENT APPROVAL LEO Pharma A/S C/o...
    • ...NDA 207589/S-001 Page 2 The SPL will be accessible from publicly available labeling repositories. Also within 14 days, amend all pending supplemental...
  9. Label

    Action date:
    FDA Application:
    NDA207589
    Drug:
    Enstilar
    Active Ingredients:
    Betamethasone dipropionate; calcipotriene
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ENSTILAR® Foam safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE Enstilar® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical...
  10. Letter

    Action date:
    FDA Application:
    NDA207589
    Drug:
    Enstilar
    Active Ingredients:
    Betamethasone dipropionate; calcipotriene
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207589 NDA APPROVAL LEO Pharma A/S C/o LEO Pharma Inc...
    • ...NDA 207589 Page 2 and As, available at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U CM072392.pdf. The SPL...