NDA 21545, held by Alcon Labs Inc. Olopatadine Hydrochloride.
As of Nov 14, 2026, NDA 21545 (Pataday Once Daily Relief), held by Alcon Labs Inc, was first approved by FDA on Dec 22, 2004, with 10 approved supplements and 0 published complete response letters.
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
| Feb 14, 2020 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Dec 22, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pataday Once Daily ReliefEQ 0.2% BASE · solution/drops;ophthalmic | Olopatadine Hydrochloride | OTCReference drug |
| Apr 15, 2025 | Supplement 29Labeling · Standard review | Approved | |
| May 13, 2021 | Supplement 24Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 23Labeling · Standard review | Approved | |
| Feb 14, 2020 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Oct 8, 2015 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Dec 8, 2010 | Supplement 13Labeling · Standard review | Approved | |
| Jun 8, 2007 | Supplement 8Labeling · Standard review | Approved | |
| Jun 8, 2007 | Supplement 9Manufacturing · Standard review | Approved | |
| Apr 26, 2007 | Supplement 6Labeling · Standard review | Approved | |
| Oct 4, 2006 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 22, 2004 | 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
