Azelastine Hydrochloride AND Fluticasone Propionate · Regulatory label update

FDA supplemental approval: Azelastine Hydrochloride AND Fluticasone Propionate (Labeling)

U.S. Food and Drug Administration · July 1, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

This record documents FDA approval of a supplemental labeling change for azelastine hydrochloride and fluticasone propionate nasal spray (APOTEX ANDA 207712), effective 2026-07-01. The record itself contains no clinical trial results, efficacy data, or safety findings; it is purely a regulatory action confirming the labeling modification.

What was studied

Regulatory label update.

Key findings

Formulation: azelastine hydrochloride 0.137 mg/spray + fluticasone propionate 0.05 mg/spray, metered nasal spray

Safety

No clinical efficacy, safety, or comparative data are reported in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA supplemental approval of labeling for an established nasal spray combination; documents a regulatory action rather than new clinical evidence.

Reported figures

Quoted from the source exactly as published.

Approval date2026-07-01

Azelastine hydrochloride dose0.137 mg/spray

Fluticasone propionate dose0.05 mg/spray

Caveats

This is a regulatory labeling supplement, not a clinical trial or evidence summary.
No clinical efficacy, safety, or comparative data are reported in this record.
The specific labeling changes made are not detailed in this source.
No information on underlying clinical studies supporting the original or supplemental approval is provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

This is a regulatory labeling action, not a clinical study.

Directness

insufficient

No clinical outcome data reported in this regulatory record.

Consistency

insufficient

No comparative or longitudinal data provided in labeling supplement.

Risk of bias

insufficient

Not applicable to a labeling approval action.

Sample adequacy

insufficient

No clinical sample or trial data reported.

Source abstract

Drugs@FDA record for application ANDA207712. This is a regulatory action record, not a clinical study. Brand name: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. Active ingredient: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. Sponsor: APOTEX. Submission type: SUPPL (supplement). Submission class: Labeling. Approval status date: 2026-07-01. Products: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, SPRAY, METERED, NASAL, AZELASTINE HYDROCHLORIDE 0.137MG/SPRAY + FLUTICASONE PROPIONATE 0.05MG/SPRAY.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Azelastine Hydrochloride AND Fluticasone PropionateApotex