Flovent Hfa

Treats asthma as prophylactic therapy. NDA 21433, held by Glaxo Grp Ltd. Fluticasone Propionate.

As of Nov 14, 2026, NDA 21433 (Flovent Hfa), held by Glaxo Grp Ltd, was first approved by FDA on May 14, 2004, with 19 approved supplements and 0 published complete response letters.

First approved: May 14, 2004
Review: Standard
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluticasone Propionate HFA is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of Use Fluticasone Propionate HFA is not indicated for the relief of acute bronchospasm. Fluticasone Propionate HFA is an inhaled corticosteroid indicated for:

Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients aged 4 years and older. Limitations of use: Not indicated for relief of acute bronchospasm.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


Feb 28, 2006	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
May 14, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Clinical Pharmacology Review

Products

3 strengths and forms


Flovent Hfa0.22MG/INH · aerosol, metered;inhalation	Fluticasone Propionate	RxReference drug
Flovent Hfa0.11MG/INH · aerosol, metered;inhalation	Fluticasone Propionate	RxReference drug
Flovent Hfa0.044MG/INH · aerosol, metered;inhalation	Fluticasone Propionate	RxReference drug

All 20 submissions, including labeling and manufacturing supplements


Aug 18, 2021	Supplement 40Labeling · Standard review	Approved	Letter Label
Jan 7, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Jul 19, 2017	Supplement 33Labeling · Standard review	Approved	Letter Label
Oct 5, 2016	Supplement 32Labeling · Standard review	Approved	Label Letter
Jul 28, 2016	Supplement 31Labeling · Standard review	Approved	Label Letter
May 20, 2016	Supplement 30Manufacturing · Standard review	Approved	None posted
Jan 6, 2016	Supplement 29Manufacturing · Standard review	Approved	None posted
Dec 10, 2014	Supplement 26Labeling · Standard review	Approved	Letter Label
Nov 14, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 17, 2014	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 17, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 18, 2013	Supplement 22Manufacturing · Standard review	Approved	Label Letter
Jun 19, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 28, 2011	Supplement 19Labeling · Standard review	Approved	Letter Label
Nov 3, 2010	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 1, 2008	Supplement 11Labeling · Standard review	Approved	Label Letter
Oct 25, 2006	Supplement 6Manufacturing · Standard review	Approved	Letter Label
Feb 28, 2006	Supplement 4Efficacy (new indication or use)	Approved	Letter Label
Dec 21, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
May 14, 2004	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric Clinical Pharmacology Review

Identifiers

Application: NDA 21433
Drugs@FDA: Overview at FDA
Company: Glaxo Group

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters