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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 020973


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NDA 020973 describes ACIPHEX, which is a drug marketed by Eisai Inc and Aytu and is included in two NDAs. It is available from one supplier. Additional details are available on the ACIPHEX profile page.

The generic ingredient in ACIPHEX is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 020973
Tradename:ACIPHEX
Applicant:Eisai Inc
Ingredient:rabeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020973
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 020973
Suppliers and Packaging for NDA: 020973
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973 NDA Eisai Inc. 62856-243 62856-243-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (62856-243-30)
Paragraph IV (Patent) Challenges for 020973
Tradename Dosage Ingredient NDA Submissiondate
ACIPHEX TABLET, DELAYED RELEASE;ORAL rabeprazole sodium 020973

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 29, 2002TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength20MG
Approval Date:Aug 19, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020973

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-002 Aug 19, 1999   Start Trial   Start Trial
Eisai Inc ACIPHEX rabeprazole sodium TABLET, DELAYED RELEASE;ORAL 020973-001 May 29, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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