General MedicationsORALStandard

ESOMEPRAZOLE MAGNESIUM

Standard Dose

EQ 5MG BASE/PACKET

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 218948 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM Form and strength FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-04-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview ESOMEPRAZOLE MAGNESIUM is listed in Drugs@FDA under application 218948 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ESOMEPRAZOLE MAGNESIUM Form and strength FOR SUSPENSION, DELAYED RELEASE;ORAL - EQ 5MG BASE/PACKET Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-04-15 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.