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General MedicationsORALStandard

OMEPRAZOLE

OMEPRAZOLE

Standard Dose
20MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OMEPRAZOLE is listed in Drugs@FDA under application 212977 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - 20MG Sponsor XIROMED Submission history Latest submission status date: 2023-07-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview OMEPRAZOLE is listed in Drugs@FDA under application 212977 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OMEPRAZOLE Form and strength CAPSULE, DELAYED REL PELLETS;ORAL - 20MG Sponsor XIROMED 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.