Drug Details Drug Name(s) ACIPHEX SPRINKLE FDA Application No. (NDA) 204736 Active Ingredient(s) RABEPRAZOLE SODIUM Company EISAI ...
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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
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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