Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021456
Company: EISAI MEDCL RES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACIPHEX RABEPRAZOLE SODIUM 20MG Tablet, Delayed Release; Oral Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/08/2002 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf

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