Advair Hfa

NDA 21254, held by Glaxo Grp Ltd. Fluticasone Propionate; Salmeterol Xinafoate.

First approved: Jun 8, 2006
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 19, 2012	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jun 8, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Advair Hfa0.045MG/INH;EQ 0.021MG BASE/INH · aerosol, metered;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	Rx · reference drug
Advair Hfa0.115MG/INH;EQ 0.021MG BASE/INH · aerosol, metered;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	Rx · reference drug
Advair Hfa0.23MG/INH;EQ 0.021MG BASE/INH · aerosol, metered;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	Rx · reference drug

All 20 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 18, 2021	Supplement 36Labeling · Standard review	Approved	Letter Label
Jan 7, 2019	Supplement 28Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 27Labeling · Standard review	Approved	Letter Label
Feb 28, 2017	Supplement 26Labeling · Standard review	Approved	Label Letter
Dec 10, 2014	Supplement 24Labeling · Standard review	Approved	Letter Label
Nov 13, 2014	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 17, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Jun 17, 2014	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 19, 2013	Supplement 20Manufacturing · Standard review	Approved	None posted
Dec 19, 2012	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 9, 2012	Supplement 19REMS	Approved	Letter
Aug 9, 2012	Supplement 18Labeling · Standard review	Approved	None posted
Jun 27, 2011	Supplement 16REMS	Approved	Letter
May 10, 2011	Supplement 15REMS	Approved	Label Letter
Jan 4, 2011	Supplement 12REMS	Approved	Letter
Jun 25, 2010	Supplement 13Labeling	Approved	Letter Label
Sep 15, 2009	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 31, 2008	Supplement 4Manufacturing	Approved	Letter
Mar 20, 2008	Supplement 3Labeling · Standard review	Approved	Label Letter
Jun 8, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21254
Drugs@FDA: Overview at FDA
Company: Glaxo Group

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