NDA 21066, held by Alcon Pharma. Ketotifen Fumarate.
As of Nov 14, 2026, NDA 21066 (Zaditor), held by Alcon Pharma, was first approved by FDA on Jul 2, 1999, with 9 approved supplements and 0 published complete response letters.
| Oct 19, 2006 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 2, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| ZaditorEQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Ketotifen Fumarate | DiscontinuedReference drug |
| May 3, 2012 | Supplement 18Labeling · Standard review | Approved | |
| Jul 9, 2008 | Supplement 13Labeling · Standard review | Approved | |
| Oct 19, 2006 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Sep 21, 2006 | Supplement 12Manufacturing | Approved | None posted |
| Oct 4, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Jul 20, 2001 | Supplement 4Labeling · Standard review | Approved | |
| Dec 26, 2000 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jul 24, 2000 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 8, 2000 | Supplement 1Labeling · Standard review | Approved | |
| Jul 2, 1999 | Original applicationNew molecular entity · 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
