Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021456
Company: EISAI MEDCL RES

• Other Important Information from FDA

Products on NDA 21456

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

Labels for NDA 021456

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