Airduo Respiclick, Airduo Digihaler

Treats asthma. NDA 208799, held by Teva Pharm. Fluticasone Propionate; Salmeterol Xinafoate.

As of Nov 13, 2026, NDA 208799 (Airduo Respiclick, Airduo Digihaler), held by Teva Pharm, was first approved by FDA on Jan 27, 2017, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2017
Review: Standard
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler (FS MDPI) is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. Fluticasone Propionate/Salmeterol MDPI should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta 2 -adrenergic agonist (LABA). Limitations of Use: Fluticasone Propionate/Salmeterol MDPI is not indicated for the relief of acute bronchospasm.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Jul 9, 2021	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 27, 2017	Original applicationNew combination · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

6 strengths and forms


Airduo Respiclick0.055MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	RxReference drug
Airduo Respiclick0.113MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	RxReference drug
Airduo Respiclick0.232MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	RxReference drug
Airduo Digihaler0.055MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	DiscontinuedReference drug
Airduo Digihaler0.113MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	DiscontinuedReference drug
Airduo Digihaler0.232MG/INH;EQ 0.014MG BASE/INH · powder;inhalation	Fluticasone Propionate; Salmeterol Xinafoate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Nov 16, 2023	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 27, 2022	Supplement 19Labeling · Standard review	Approved	Label Letter
Jul 9, 2021	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Letter Label
Feb 21, 2020	Supplement 11Labeling · Standard review	Approved	Label Letter
Mar 2, 2018	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 20, 2017	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 27, 2017	Original applicationNew combination · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 208799
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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