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General MedicationsSUBCUTANEOUSGeneric

BYDUREON PEN

EXENATIDE SYNTHETIC

Standard Dose
2MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview BYDUREON PEN is listed in Drugs@FDA under application 022200 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient EXENATIDE SYNTHETIC Form and strength FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2025-05-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview BYDUREON PEN is listed in Drugs@FDA under application 022200 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient EXENATIDE SYNTHETIC Form and strength FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2025-05-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.