NDA 22429, held by Bionpharma. Cetirizine Hydrochloride.
As of Nov 14, 2026, NDA 22429 (Cetirizine Hydrochloride Allergy, Cetirizine Hydrochloride Hives Relief), held by Bionpharma, was first approved by FDA on Jul 23, 2009, with 5 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Cetirizine Hydrochloride Allergy5MG · capsule;oral | Cetirizine Hydrochloride | OTCReference drug |
| Cetirizine Hydrochloride Hives Relief10MG · capsule;oral | Cetirizine Hydrochloride | OTCReference drug |
| Cetirizine Hydrochloride Hives Relief5MG · capsule;oral | Cetirizine Hydrochloride | OTCReference drug |
| Cetirizine Hydrochloride Allergy10MG · capsule;oral | Cetirizine Hydrochloride | OTCReference drug |
| Jan 30, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Dec 7, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Dec 13, 2019 | Supplement 14Manufacturing | Approved | |
| Feb 6, 2013 | Supplement 9Labeling · Standard review | Approved | |
| Apr 6, 2010 | Supplement 3Manufacturing · Standard review | Approved | |
| Jul 23, 2009 | Original applicationNew dosage form · Standard 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
