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General MedicationsORALStandard

OMEPRAZOLE AND SODIUM BICARBONATE

OMEPRAZOLE; SODIUM BICARBONATE

Standard Dose
40MG/PACKET;1.68GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OMEPRAZOLE AND SODIUM BICARBONATE is listed in Drugs@FDA under application 219161 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE; SODIUM BICARBONATE Form and strength FOR SUSPENSION;ORAL - 40MG/PACKET;1.68GM/PACKET Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2025-12-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMEPRAZOLE AND SODIUM BICARBONATE is listed in Drugs@FDA under application 219161 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE; SODIUM BICARBONATE Form and strength FOR SUSPENSION;ORAL - 40MG/PACKET;1.68GM/PACKET Sponsor NOVITIUM PHARMA Submission history Latest submission status date: 2025-12-10 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.