Flovent Diskus 50, Flovent Diskus 100, Flovent Diskus 250

Treats asthma as prophylactic therapy. NDA 20833, held by Glaxo Grp Ltd. Fluticasone Propionate.

As of Nov 13, 2026, NDA 20833 (Flovent Diskus 50, Flovent Diskus 100, Flovent Diskus 250), held by Glaxo Grp Ltd, was first approved by FDA on Sep 29, 2000, with 17 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2000
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FLOVENT DISKUS is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important Limitation of Use FLOVENT DISKUS is NOT indicated for the relief of acute bronchospasm. FLOVENT DISKUS is an inhaled corticosteroid (ICS) indicated for:

Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older. Important limitation:
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 18 submissions below

Date	Submission	Status	Documents
Sep 29, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter

Products

3 strengths and forms


Flovent Diskus 500.05MG/INH · powder;inhalation	Fluticasone Propionate	RxReference drug
Flovent Diskus 1000.1MG/INH · powder;inhalation	Fluticasone Propionate	RxReference drug
Flovent Diskus 2500.25MG/INH · powder;inhalation	Fluticasone Propionate	RxReference drug

All 18 submissions, including labeling and manufacturing supplements


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
Nov 13, 2014	Supplement 30Labeling · Standard review	Approved	Letter
Jun 17, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Apr 14, 2014	Supplement 28Labeling · Standard review	Approved	Letter Label
Jun 19, 2013	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 5, 2012	Supplement 26Manufacturing · Standard review	Approved	None posted
May 3, 2010	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 14, 2005	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 31, 2005	Supplement 14Labeling · Standard review	Approved	Letter Label
Dec 17, 2004	Supplement 12Manufacturing · Standard review	Approved	Letter Label
Nov 1, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Nov 1, 2002	Supplement 2Labeling · Standard review	Approved	Letter
May 15, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 5, 2002	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 29, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 20833
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