NDA 21861, held by Novartis. Olopatadine Hydrochloride.
As of Nov 15, 2026, NDA 21861 (Patanase), held by Novartis, was first approved by FDA on Apr 15, 2008, with 7 approved supplements and 0 published complete response letters.
| Mar 31, 2010 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2009 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jun 17, 2009 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Apr 15, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Patanase0.665MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · spray, metered;nasal | Olopatadine Hydrochloride | DiscontinuedReference drug |
| Mar 4, 2021 | Supplement 15Labeling · Standard review | Approved | |
| Jul 27, 2016 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 27, 2015 | Supplement 11Labeling · Standard review | Approved | |
| Feb 22, 2012 | Supplement 9Labeling · Standard review | Approved | |
| Mar 31, 2010 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2009 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jun 17, 2009 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Apr 15, 2008 | 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
