Armonair Respiclick, Armonair Digihaler

NDA 208798, held by Teva Pharm. Fluticasone Propionate.

As of Nov 13, 2026, NDA 208798 (Armonair Respiclick, Armonair 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

Approvals and New Uses

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

Date	Submission	Status	Documents
Jul 9, 2021	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 27, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

8 strengths and forms

Product	Active ingredient	Marketing
Armonair Respiclick0.055MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Respiclick0.113MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Respiclick0.232MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Digihaler0.055MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Digihaler0.113MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Digihaler0.232MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Respiclick0.03MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug
Armonair Digihaler0.03MG/INH · powder;inhalation	Fluticasone Propionate	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 16, 2023	Supplement 16Labeling · Standard review	Approved	Label Letter
Apr 8, 2022	Supplement 13Manufacturing	Approved	Letter Label
Jan 27, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jul 9, 2021	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Letter Label
Sep 18, 2020	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 2, 2018	Supplement 2Labeling · Standard review	Approved	Letter Label
Jan 27, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 208798
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