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Drug Details

Drug Name(s)                 ACIPHEX SPRINKLE
FDA Application No.         (NDA) 204736
Active Ingredient(s)        RABEPRAZOLE SODIUM
Company                        EISAI INC
Original Approval or Tentative Approval Date        March 26, 2013
Chemical Type                 3  New dosage form
Review Classification         P  Priority review drug  


Products on Application (NDA) #204736
    Click on a column header to re-sort the table:

Drug Name           Active Ingredients        Strength        Dosage Form/Route        Marketing    Status        RLD        TE Code
ACIPHEX SPRINKLE         RABEPRAZOLE SODIUM         5MG         CAPSULE, DELAYED RELEASE;ORAL         Prescription         No         None  
ACIPHEX SPRINKLE         RABEPRAZOLE SODIUM         10MG         CAPSULE, DELAYED RELEASE;ORAL         Prescription         Yes         None
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