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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 Fsc Therap and is included in two NDAs. It is available from seven suppliers. Additional details are available on the ACIPHEX profile page.

The generic ingredient in ACIPHEX is rabeprazole sodium. There are twenty-nine drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for NDA: 020973

Tradename:
ACIPHEX
Applicant:
Eisai Inc
Ingredient:
rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020973

Mechanism of ActionProton Pump Inhibitors

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 Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC 49999-447 49999-447-30 30 TABLET, COATED in 1 BOTTLE (49999-447-30)
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL 020973 NDA Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC 49999-447 49999-447-90 90 TABLET, COATED in 1 BOTTLE (49999-447-90)

Summary 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DELAYED RELEASE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No

Summary for product number 002

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

Expired Orange Book Patents for NDA: 020973

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 20025,035,899► subscribe
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-002Aug 19, 19995,045,552*PED► subscribe
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-002Aug 19, 19995,035,899► subscribe
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