Qvar 80, Qvar 40

NDA 20911, held by Teva Branded Pharm. Beclomethasone Dipropionate.

As of Nov 14, 2026, NDA 20911 (Qvar 80, Qvar 40), held by Teva Branded Pharm, was first approved by FDA on Sep 15, 2000, with 18 approved supplements and 0 published complete response letters.

First approved: Sep 15, 2000
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


May 10, 2002	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter
Sep 15, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

2 strengths and forms


Qvar 800.08MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · aerosol, metered;inhalation	Beclomethasone Dipropionate	DiscontinuedReference drug
Qvar 400.04MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · aerosol, metered;inhalation	Beclomethasone Dipropionate	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Sep 29, 2017	Supplement 30Labeling · Standard review	Approved	Patient Information Sheet Label Letter
Sep 29, 2017	Supplement 29Labeling · Standard review	Approved	Patient Information Sheet Label Letter
Dec 16, 2015	Supplement 27Manufacturing · Standard review	Approved	None posted
Mar 9, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Jul 21, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
May 22, 2014	Supplement 26Manufacturing · Standard review	Approved	Label Letter
May 8, 2013	Supplement 23Manufacturing · Standard review	Approved	None posted
Jul 30, 2012	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 18, 2008	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 20, 2006	Supplement 15Labeling · Standard review	Approved	Label Letter
Aug 1, 2003	Supplement 8Labeling · Standard review	Approved	Letter
Jul 11, 2002	Supplement 7Manufacturing · Standard review	Approved	None posted
May 10, 2002	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter
Jan 17, 2002	Supplement 6Manufacturing · Standard review	Approved	None posted
Aug 2, 2001	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 17, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 27, 2001	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 1, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 15, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 20911
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