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General MedicationsINHALATIONStandard

BUDESONIDE

BUDESONIDE

Standard Dose
0.5MG/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 216667 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SUSPENSION;INHALATION - 0.5MG/2ML Sponsor EUGIA PHARMA Submission history Latest submission status date: 2023-11-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUDESONIDE is listed in Drugs@FDA under application 216667 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SUSPENSION;INHALATION - 0.5MG/2ML Sponsor EUGIA PHARMA Submission history Latest submission status date: 2023-11-29 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.