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General MedicationsORALStandard

PRILOSEC

OMEPRAZOLE MAGNESIUM

Standard Dose
EQ 10MG BASE/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PRILOSEC is listed in Drugs@FDA under application 022056 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE MAGNESIUM Form and strength FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET Sponsor AZURITY Submission history Latest submission status date: 2023-07-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview PRILOSEC is listed in Drugs@FDA under application 022056 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE MAGNESIUM Form and strength FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 10MG BASE/PACKET Sponsor AZURITY Submission history Latest submission status date: 2023-07-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
PRILOSEC (OMEPRAZOLE MAGNESIUM) | Drug Monograph | MedicHelpline