Symbicort Aerosphere

NDA 216579, held by Astrazeneca. Budesonide; Formoterol Fumarate.

As of Nov 13, 2026, NDA 216579 (Symbicort Aerosphere), held by Astrazeneca, was first approved by FDA on Apr 28, 2023, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2023
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below


Apr 27, 2026	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 28, 2023	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label

Products

2 strengths and forms


Symbicort Aerosphere0.16MG/INH;0.0048MG/INH · aerosol, metered;inhalation	Budesonide; Formoterol Fumarate	RxReference drug
Symbicort Aerosphere0.08MG/INH;0.0048MG/INH · aerosol, metered;inhalation	Budesonide; Formoterol Fumarate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Oct 23, 2026	Supplement 2Labeling · Standard review	Approved	Letter Label
Apr 27, 2026	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 28, 2023	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label

Identifiers

Application: NDA 216579
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