Proair Respiclick, Proair Digihaler

Prevents bronchospasm. NDA 205636, held by Teva Branded Pharm. Albuterol Sulfate.

As of Nov 14, 2026, NDA 205636 (Proair Respiclick, Proair Digihaler), held by Teva Branded Pharm, was first approved by FDA on Mar 31, 2015, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 31, 2015
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ProAir Digihaler is a beta 2 -adrenergic agonist indicated for: Treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. Prevention of exercise-induced bronchospasm in patients 4 years of age and older. 1.1 Bronchospasm ProAir Digihaler is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. 1.2 Exercise-Induced Bronchospasm ProAir Digihaler is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Apr 28, 2016	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 31, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


Proair RespiclickEQ 0.09MG BASE/INH · powder, metered;inhalation	Albuterol Sulfate	RxReference drug
Proair DigihalerEQ 0.09MG BASE/INH · powder, metered;inhalation	Albuterol Sulfate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Aug 28, 2023	Supplement 28Labeling · Standard review	Approved	None posted
Jan 27, 2022	Supplement 23Labeling · Standard review	Approved	None posted
Sep 29, 2020	Supplement 20Labeling · Standard review	Approved	Label Letter
Jan 9, 2019	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 8, 2016	Supplement 6Labeling · Standard review	Approved	Letter Label
May 11, 2016	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 28, 2016	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Dec 11, 2015	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 30, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 30, 2015	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 31, 2015	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205636
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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