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General MedicationsORALGeneric

YOSPRALA

ASPIRIN; OMEPRAZOLE

Standard Dose
81MG;40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview YOSPRALA is listed in Drugs@FDA under application 205103 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; OMEPRAZOLE Form and strength TABLET, DELAYED RELEASE;ORAL - 81MG;40MG Sponsor GENUS LIFESCIENCES Submission history Latest submission status date: 2024-11-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview YOSPRALA is listed in Drugs@FDA under application 205103 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ASPIRIN; OMEPRAZOLE Form and strength TABLET, DELAYED RELEASE;ORAL - 81MG;40MG Sponsor GENUS LIFESCIENCES Submission history Latest submission status date: 2024-11-21 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.