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General MedicationsINHALATIONStandard

BRONCHITOL

MANNITOL

Standard Dose
40MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BRONCHITOL is listed in Drugs@FDA under application 202049 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient MANNITOL Form and strength POWDER;INHALATION - 40MG Sponsor PHARMAXIS EUROPE Submission history Latest submission status date: 2020-10-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview BRONCHITOL is listed in Drugs@FDA under application 202049 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient MANNITOL Form and strength POWDER;INHALATION - 40MG Sponsor PHARMAXIS EUROPE Submission history Latest submission status date: 2020-10-30 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.