Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALGeneric

PRILOSEC

OMEPRAZOLE

Standard Dose
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview PRILOSEC is listed in Drugs@FDA under application 019810 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEPRAZOLE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ASTRAZENECA Submission history Latest submission status date: 2016-12-19 00:00:00.

Structured Monograph

Clinical summary

Approval overview PRILOSEC is listed in Drugs@FDA under application 019810 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient OMEPRAZOLE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor ASTRAZENECA Submission history Latest submission status date: 2016-12-19 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.