NDA 22368, held by Pharmaxis Europe. Mannitol.
As of Nov 13, 2026, NDA 22368 (Aridol Kit, Aridol), held by Pharmaxis Europe, was first approved by FDA on Oct 5, 2010, with 1 approved supplement and 0 published complete response letters.
ARIDOL is indicated for the assessment of bronchial hyperresponsiveness in adult and pediatric patients 6 years of age or older who do not have clinically apparent asthma. Limitations of Use: ARIDOL is not a standalone test or a screening test for asthma. Bronchial challenge testing with ARIDOL should be used only as part of a physician's overall assessment of asthma.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Aug 13, 2021 | Supplement 3Labeling · Standard review | Approved | |
| Oct 5, 2010 | 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
