Qnasl

Treats nasal symptoms associated with seasonal and perennial allergic rhinitis. NDA 202813, held by Teva Branded Pharm. Beclomethasone Dipropionate.

As of Nov 13, 2026, NDA 202813 (Qnasl), held by Teva Branded Pharm, was first approved by FDA on Mar 23, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 23, 2012
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE QNASL Nasal Aerosol is a corticosteroid indicated for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis in patients 4 years of age and older. 1.1 Treatment of Nasal Symptoms of Allergic Rhinitis QNASL Nasal Aerosol is indicated for the treatment of the nasal symptoms associated with seasonal and perennial allergic rhinitis 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


Dec 17, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2014	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 23, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


Qnasl0.08MG/ACTUATION · aerosol, metered;nasal	Beclomethasone Dipropionate	RxReference drug
Qnasl0.04MG/ACTUATION · aerosol, metered;nasal	Beclomethasone Dipropionate	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Mar 30, 2018	Supplement 12Manufacturing · Standard review	Approved	Label
Jul 26, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 29, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 17, 2014	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2014	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 10, 2014	Supplement 6Labeling · Standard review	Approved	Letter
Mar 19, 2014	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 29, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 23, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202813
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