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General MedicationsINHALATIONGeneric

UTIBRON NEOHALER

GLYCOPYRROLATE; INDACATEROL MALEATE

Standard Dose
15.6MCG/INH;27.5MCG/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview UTIBRON NEOHALER is listed in Drugs@FDA under application 207930 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYCOPYRROLATE; INDACATEROL MALEATE Form and strength POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH Sponsor NOVARTIS Submission history Latest submission status date: 2021-07-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview UTIBRON NEOHALER is listed in Drugs@FDA under application 207930 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GLYCOPYRROLATE; INDACATEROL MALEATE Form and strength POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH Sponsor NOVARTIS Submission history Latest submission status date: 2021-07-30 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
UTIBRON NEOHALER (GLYCOPYRROLATE; INDACATEROL MALEATE) | Drug Monograph | MedicHelpline