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General MedicationsINHALATIONStandard

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Standard Dose
0.5MG/INH;EQ 0.05MG BASE/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is listed in Drugs@FDA under application 213948 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Form and strength POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2021-12-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is listed in Drugs@FDA under application 213948 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE Form and strength POWDER;INHALATION - 0.5MG/INH;EQ 0.05MG BASE/INH Sponsor TEVA PHARMS USA Submission history Latest submission status date: 2021-12-13 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.