NDA 21257, held by Alcon Pharms Ltd. Travoprost.
As of Nov 14, 2026, NDA 21257 (Travatan), held by Alcon Pharms Ltd, was first approved by FDA on Mar 16, 2001, with 15 approved supplements and 0 published complete response letters.
| Aug 31, 2010 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Feb 13, 2003 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2001 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Travatan0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Travoprost | DiscontinuedReference drug |
| Sep 7, 2011 | Supplement 25Labeling | Approved | |
| Aug 31, 2010 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Jan 23, 2006 | Supplement 15Labeling · Standard review | Approved | |
| Jan 23, 2006 | Supplement 14Manufacturing · Priority review | Approved | |
| Feb 20, 2004 | Supplement 13Labeling · Standard review | Approved | |
| Feb 20, 2004 | Supplement 12Manufacturing · Priority review | Approved | |
| May 15, 2003 | Supplement 10Manufacturing · Priority review | Approved | |
| Feb 13, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Feb 13, 2003 | Supplement 8Labeling · Standard review | Approved | |
| Feb 13, 2003 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 4, 2002 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Dec 4, 2002 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Aug 28, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Mar 25, 2002 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Feb 15, 2002 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Mar 16, 2001 | 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
