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General MedicationsSUBCUTANEOUSStandard

BYETTA

EXENATIDE SYNTHETIC

Standard Dose
300UGM/1.2ML (250UGM/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BYETTA is listed in Drugs@FDA under application 021919 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient EXENATIDE SYNTHETIC Form and strength INJECTABLE; SUBCUTANEOUS - 300UGM/1.2ML (250UGM/ML) Sponsor AMYLIN Submission history Latest submission status date: 2009-10-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview BYETTA is listed in Drugs@FDA under application 021919 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient EXENATIDE SYNTHETIC Form and strength INJECTABLE; SUBCUTANEOUS - 300UGM/1.2ML (250UGM/ML) Sponsor AMYLIN Submission history Latest submission status date: 2009-10-30 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.