Symbicort

Treats asthma. NDA 21929, held by Astrazeneca. Budesonide; Formoterol Fumarate Dihydrate.

As of Nov 14, 2026, NDA 21929 (Symbicort), held by Astrazeneca, was first approved by FDA on Jul 21, 2006, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 21, 2006
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for:

Treatment of asthma in patients 6 years of age and older.
Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. Important limitations:
Not indicated for the relief of acute bronchospasm. ( 1.1, 1.2 ) 1.1 Treatment of Asthma BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Dec 20, 2017	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 11, 2017	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2017	Supplement 13Efficacy (new indication or use)	Approved	Letter Label Pediatric Amendment 4 Pediatric Amendment 3
Feb 27, 2009	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 21, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Symbicort0.08MG/INH;0.0045MG/INH · aerosol, metered;inhalation	Budesonide; Formoterol Fumarate Dihydrate	RxReference drug
Symbicort0.16MG/INH;0.0045MG/INH · aerosol, metered;inhalation	Budesonide; Formoterol Fumarate Dihydrate	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Dec 20, 2017	Supplement 42Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 11, 2017	Supplement 41Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2017	Supplement 13Efficacy (new indication or use)	Approved	Letter Label Pediatric Amendment 4 Pediatric Amendment 3
Jun 10, 2016	Supplement 40Manufacturing · Standard review	Approved	None posted
Apr 14, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 28, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Apr 4, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
Feb 27, 2014	Supplement 36Manufacturing · Standard review	Approved	None posted
Jan 15, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 23, 2012	Supplement 33REMS	Approved	Letter
May 8, 2012	Supplement 30Manufacturing	Approved	None posted
Aug 18, 2011	Supplement 28REMS	Approved	Letter
Feb 16, 2011	Supplement 19REMS	Approved	Letter
Jun 25, 2010	Supplement 21Labeling	Approved	Letter Label
Feb 27, 2009	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jul 16, 2008	Supplement 10Labeling · Standard review	Approved	Letter Label
Oct 31, 2007	Supplement 4Labeling · Standard review	Approved	Letter Label
Oct 26, 2007	Supplement 6Manufacturing · Standard review	Approved	Letter Label
Jul 21, 2006	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21929
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

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