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OSP finalist
Action period
  1. Letter

    Action date:
    FDA Application:
    NDA208246
    Drug:
    Xeljanz xr
    Active Ingredients:
    Tofacitinib citrate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208246 NDA APPROVAL Pfizer, Inc. 445 Eastern Point...
    • ...NDA 208246 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed...
  2. Label

    Action date:
    FDA Application:
    NDA208223
    Drug:
    Zembrace symtouch
    Active Ingredients:
    Sumatriptan succinate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEMBRACE™ SymTouch™ safely and effectively...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ZEMBRACE SymTouch is indicated for the acute treatment of migraine with or without aura...
  3. Letter

    Action date:
    FDA Application:
    NDA208223
    Drug:
    Zembrace symtouch
    Active Ingredients:
    Sumatriptan succinate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208-223 NDA APPROVAL Dr. Reddy’s Laboratories, Inc...
    • ...NDA 208-223 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...
  4. Label

    Action date:
    FDA Application:
    NDA208216
    Drug:
    Azacitidine
    Active Ingredients:
    Azacitidine
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AZACITIDINE FOR INJECTION safely...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment...
  5. Letter

    Action date:
    FDA Application:
    NDA208216
    Drug:
    Azacitidine
    Active Ingredients:
    Azacitidine
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208216 NDA APPROVAL Actavis, LLC Attention: Joann...
    • ...NDA 208216 Page 2 The SPL will be accessible via publicly available labeling repositories. CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your...
  6. Label

    Action date:
    FDA Application:
    NDA208215
    Drug:
    Descovy
    Active Ingredients:
    Emtricitabine; tenofovir alafenamide fumarate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use DESCOVY safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B Lactic...
  7. Letter

    Action date:
    FDA Application:
    NDA208215
    Drug:
    Descovy
    Active Ingredients:
    Emtricitabine; tenofovir alafenamide fumarate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208215/Original 1 NDA APPROVAL Gilead Sciences, Inc...
    • ...NDA 208215/Original 1 Page 2 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of labeling must...
  8. Label

    Action date:
    FDA Application:
    NDA208194
    Drug:
    Bendeka
    Active Ingredients:
    Bendamustine hydrochloride
    • ...monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions (4, 5.3) HIGHLIGHTS OF PRESCRIBING...
    • ...14.1 Chronic Lymphocytic Leukemia (CLL) 14.2 Non-Hodgkin Lymphoma (NHL) 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Safe Handling...
  9. Letter

    Action date:
    FDA Application:
    NDA208194
    Drug:
    Bendeka
    Active Ingredients:
    Bendamustine hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208194/S-001 NDA 208194/S-002 SUPPLEMENT APPROVAL...
    • ...NDA 208194/S-001 NDA 208194/S-002 Page 2 automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry...
  10. Label

    Action date:
    FDA Application:
    NDA208194
    Drug:
    Bendeka
    Active Ingredients:
    Bendamustine hydrochloride
    • ...monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions (4, 5.3) HIGHLIGHTS OF PRESCRIBING...
    • ...14.1 Chronic Lymphocytic Leukemia (CLL) 14.2 Non-Hodgkin Lymphoma (NHL) 15 REFERENCES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Safe Handling...