NDA 206276, held by Alcon Labs Inc. Olopatadine Hydrochloride.
As of Nov 13, 2026, NDA 206276 (Pataday Once Daily Relief), held by Alcon Labs Inc, was first approved by FDA on Jan 30, 2015, with 4 approved supplements and 0 published complete response letters.
Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander
| Jul 13, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2015 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pataday Once Daily ReliefEQ 0.7% BASE · solution/drops;ophthalmic | Olopatadine Hydrochloride | OTCReference drug |
| Apr 15, 2025 | Supplement 11Labeling · Standard review | Approved | |
| Oct 25, 2021 | Supplement 6Manufacturing | Approved | |
| Jul 13, 2020 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Nov 27, 2015 | Supplement 1Manufacturing · Priority review | Approved | |
| Jan 30, 2015 | 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
