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General MedicationsORALStandard

KONVOMEP

OMEPRAZOLE; SODIUM BICARBONATE

Standard Dose
2MG/ML;84MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KONVOMEP is listed in Drugs@FDA under application 213593 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE; SODIUM BICARBONATE Form and strength FOR SUSPENSION;ORAL - 2MG/ML;84MG/ML Sponsor AZURITY Submission history Latest submission status date: 2022-08-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview KONVOMEP is listed in Drugs@FDA under application 213593 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE; SODIUM BICARBONATE Form and strength FOR SUSPENSION;ORAL - 2MG/ML;84MG/ML Sponsor AZURITY Submission history Latest submission status date: 2022-08-30 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.