Relieves symptoms associated with perennial allergic rhinitis. NDA 22064, held by Chattem Sanofi. Levocetirizine Dihydrochloride.
As of Nov 15, 2026, NDA 22064 (Xyzal), held by Chattem Sanofi, was first approved by FDA on May 25, 2007, with 18 approved supplements and 0 published complete response letters.
XYZAL is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria 1.1 Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 1.2 Chronic Idiopathic Urticaria XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
| Aug 21, 2009 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| May 25, 2007 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xyzal5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Levocetirizine Dihydrochloride | DiscontinuedReference drug |
| Jul 11, 2025 | Supplement 40Labeling | Approved | |
| Apr 2, 2019 | Supplement 38Labeling · Standard review | Approved | |
| Jan 11, 2019 | Supplement 37Labeling · Standard review | Approved | |
| Apr 2, 2018 | Supplement 36Labeling · Standard review | Approved | |
| Oct 16, 2017 | Supplement 34Labeling · Standard review | Approved | |
| Jul 10, 2017 | Supplement 33Labeling · Standard review | Approved | |
| Feb 9, 2017 | Supplement 31Labeling · Standard review | Approved | |
| Nov 8, 2016 | Supplement 32Labeling · Standard review | Approved | |
| Jun 23, 2016 | Supplement 30Labeling · Standard review | Approved | |
| Feb 14, 2014 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Nov 7, 2013 | Supplement 28Labeling · Standard review | Approved | |
| Nov 20, 2012 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Sep 6, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Mar 7, 2011 | Supplement 20Labeling · Standard review | Approved | |
| Aug 21, 2009 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 31, 2008 | Supplement 9Labeling · Standard review | Approved | |
| Feb 1, 2008 | Supplement 5Labeling · Standard review | Approved | |
| Oct 18, 2007 | Supplement 2Manufacturing | Approved | None posted |
| May 25, 2007 | Original applicationNew formulation or manufacturer · Priority review | Approved |
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
