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General MedicationsNASALStandard

BUDESONIDE

BUDESONIDE

Standard Dose
0.032MG/INH
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 078949 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SPRAY, METERED;NASAL - 0.032MG/INH Sponsor APOTEX Submission history Latest submission status date: 2019-10-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview BUDESONIDE is listed in Drugs@FDA under application 078949 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient BUDESONIDE Form and strength SPRAY, METERED;NASAL - 0.032MG/INH Sponsor APOTEX Submission history Latest submission status date: 2019-10-29 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.