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OSP finalist
Action period
  1. 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...
  2. Label

    Action date:
    FDA Application:
    NDA208194
    Drug:
    Bendeka
    Active Ingredients:
    Bendamustine hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BENDEKA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Chronic Lymphocytic Leukemia (CLL) BENDEKA (bendamustine hydrochloride) Injection...
  3. 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 NDA APPROVAL Eagle Pharmaceuticals, Inc...
    • ...NDA 208194 Page 2 of labeling must be identical to the enclosed labeling (text for the package insert). Information on submitting SPL files using...
  4. Label

    Action date:
    FDA Application:
    NDA208183
    Drug:
    Ultravate
    Active Ingredients:
    Halobetasol propionate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ULTRAVATE® lotion safely and effectively. See...
    • ...FULL PRESCRIBING INFORMATION 1. INDICATIONS AND USAGE ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients...
  5. Letter

    Action date:
    FDA Application:
    NDA208183
    Drug:
    Ultravate
    Active Ingredients:
    Halobetasol propionate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208183 NDA APPROVAL Ferndale Laboratories, Inc...
    • ...NDA 208183 Page 2 available, but no more than 30 days after they are printed. Please submit these labels electronically according to the guidance...
  6. Summary Review

    Action date:
    FDA Application:
    NDA208183
    Drug:
    Ultravate
    Active Ingredients:
    Halobetasol propionate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLI CA I 0N NUMBER: 2081830rig15000 SUMMARY REVIEW...
    • ...DTL and Siunmary Review Ultravate (halobetasol propionate) lotion. 0.05% CDTL and Summary Review for Regulatory Action...
  7. Label

    Action date:
    FDA Application:
    NDA208169
    Drug:
    Xuriden
    Active Ingredients:
    Uridine triacetate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use XURIDEN safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE XURIDENTM is indicated for the treatment of hereditary orotic aciduria. 2 2.1 DOSAGE...
  8. Letter

    Action date:
    FDA Application:
    NDA208169
    Drug:
    Xuriden
    Active Ingredients:
    Uridine triacetate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208169 NDA APPROVAL Wellstat Therapeutics...
    • ...NDA 208169 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...
  9. Summary Review

    Action date:
    FDA Application:
    NDA208169
    Drug:
    Xuriden
    Active Ingredients:
    Uridine triacetate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2081690rig15000 SUMMARY REVIEW...
    • ...Division Director Review Summary Review for Regulatory Action Date (electronic stamp) From Dragos Roman, MD, Acting...
  10. Label

    Action date:
    FDA Application:
    NDA208159
    Drug:
    Vistogard
    Active Ingredients:
    Uridine triacetate
    • ...(uridine triacetate) oral granules 10g Packet NDC 69468-151-20 Carton contains 20 x 10 gram packets NDC 69468-151-20 NDC 69468-151-20 3...
    • ...Only Each carton contains 4 packets. Each single-dose packet contains 10 g of uridine triacetate. Directions for use: Each Vistogard ® dose should...