NDA 20688, held by Alcon Labs Inc. Olopatadine Hydrochloride.
As of Nov 13, 2026, NDA 20688 (Pataday Twice Daily Relief), held by Alcon Labs Inc, was first approved by FDA on Dec 18, 1996, with 21 approved supplements and 0 published complete response letters.
Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander
| Feb 14, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Mar 20, 2000 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Dec 18, 1996 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pataday Twice Daily ReliefEQ 0.1% BASE · solution/drops;ophthalmic | Olopatadine Hydrochloride | OTCReference drug |
| Apr 15, 2025 | Supplement 37Labeling · Standard review | Approved | |
| Sep 30, 2020 | Supplement 33Labeling · Standard review | Approved | |
| Feb 14, 2020 | Supplement 32Efficacy (new indication or use) · Standard review | Approved | |
| Jun 30, 2015 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Sep 12, 2013 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2003 | Supplement 16Labeling · Standard review | Approved | |
| Mar 13, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 24, 2001 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 16, 2001 | Supplement 13Manufacturing · Standard review | Approved | |
| Mar 20, 2000 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Feb 18, 2000 | Supplement 11Manufacturing · Standard review | Approved | |
| Sep 28, 1999 | Supplement 9Manufacturing · Standard review | Approved | |
| Aug 19, 1999 | Supplement 4Manufacturing · Standard review | Approved | |
| Aug 17, 1999 | Supplement 10Manufacturing · Standard review | Approved | |
| Mar 11, 1999 | Supplement 6Manufacturing · Standard review | Approved | |
| Feb 16, 1999 | Supplement 8Manufacturing · Standard review | Approved | |
| Feb 5, 1999 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 14, 1998 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1998 | Supplement 2Manufacturing · Standard review | Approved | |
| May 29, 1998 | Supplement 3Labeling · Standard review | Approved | |
| Jan 15, 1998 | Supplement 1Manufacturing · Standard review | Approved | |
| Dec 18, 1996 | Original applicationNew molecular entity · 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
