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Details for Generic Name: rabeprazole sodium

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Rabeprazole sodium is the generic ingredient in three branded drugs marketed by Eisai Inc, Dr Reddys Labs Ltd, Kremers Urban Dev, Lupin Ltd, Mylan Pharms Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for rabeprazole sodium. Eight suppliers are listed for this compound.

Summary for Generic Name: rabeprazole sodium

Tradenames:3
Patents:0
Applicants:7
NDAs:8
Drug Master File Entries: see list29
Suppliers / Packaging: see list17
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: rabeprazole sodium

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Clinical Trials for: rabeprazole sodium

A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
Status: Completed Condition: Gastroesophageal Reflux

A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers
Status: Completed Condition: Healthy

A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Status: Completed Condition: Healthy

A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL078964-001Nov 8, 2013RXNo<disabled><disabled>
Eisai Inc
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-001Mar 26, 2013RXNo<disabled><disabled>
Eisai Inc
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-002Mar 26, 2013RXYes<disabled><disabled>
Eisai Inc
ACIPHEX
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL020973-001May 29, 2002DISCNNo<disabled><disabled>
Dr Reddys Labs Ltd
RABEPRAZOLE SODIUM
rabeprazole sodium
TABLET, DELAYED RELEASE;ORAL076824-001Nov 8, 2013RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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