General MedicationsINHALATIONStandard

BUDESONIDE

Standard Dose

1MG/2ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview BUDESONIDE is listed in Drugs@FDA under application 211922 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SUSPENSION;INHALATION - 1MG/2ML Sponsor SUN PHARM Submission history Latest submission status date: 2023-09-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUDESONIDE is listed in Drugs@FDA under application 211922 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SUSPENSION;INHALATION - 1MG/2ML Sponsor SUN PHARM Submission history Latest submission status date: 2023-09-20 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.