General MedicationsORALStandard

PANTOPRAZOLE SODIUM

Standard Dose

EQ 20MG BASE

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview PANTOPRAZOLE SODIUM is listed in Drugs@FDA under application 219087 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PANTOPRAZOLE SODIUM Form and strength TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE Sponsor GRAVITI PHARMS Submission history Latest submission status date: 2025-01-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview PANTOPRAZOLE SODIUM is listed in Drugs@FDA under application 219087 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PANTOPRAZOLE SODIUM Form and strength TABLET, DELAYED RELEASE;ORAL - EQ 20MG BASE Sponsor GRAVITI PHARMS Submission history Latest submission status date: 2025-01-16 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.