General MedicationsSUBCUTANEOUSGeneric

BYDUREON BCISE

EXENATIDE SYNTHETIC

Standard Dose

2MG/0.85ML (2MG/0.85ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview BYDUREON BCISE is listed in Drugs@FDA under application 209210 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient EXENATIDE SYNTHETIC Form and strength SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG/0.85ML (2MG/0.85ML) Sponsor ASTRAZENECA AB Submission history Latest submission status date: 2025-05-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview BYDUREON BCISE is listed in Drugs@FDA under application 209210 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient EXENATIDE SYNTHETIC Form and strength SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS - 2MG/0.85ML (2MG/0.85ML) 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.