Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020973

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ACIPHEX (RABEPRAZOLE SODIUM)
20MG
Marketing Status: Prescription

Active Ingredient: RABEPRAZOLE SODIUM
Proprietary Name: ACIPHEX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020973
Product Number: 002
Approval Date: Aug 19, 1999
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ACIPHEX (RABEPRAZOLE SODIUM)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: RABEPRAZOLE SODIUM
Proprietary Name: ACIPHEX
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020973
Product Number: 001
Approval Date: May 29, 2002
Applicant Holder Full Name: WAYLIS THERAPEUTICS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information