NDA 20869, held by Thea Pharma. Dorzolamide Hydrochloride; Timolol Maleate.
As of Nov 13, 2026, NDA 20869 (Cosopt), held by Thea Pharma, was first approved by FDA on Apr 7, 1998, with 22 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 7, 1998 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CosoptEQ 2% BASE;EQ 0.5% BASE · solution/drops;ophthalmic | Dorzolamide Hydrochloride; Timolol Maleate | RxReference drug |
| Nov 23, 2020 | Supplement 42Labeling · Standard review | Approved | |
| Jul 31, 2015 | Supplement 40Labeling · Standard review | Approved | |
| Jun 18, 2010 | Supplement 36Labeling · Standard review | Approved | |
| Oct 22, 2008 | Supplement 34Labeling · Standard review | Approved | |
| Aug 9, 2006 | Supplement 30Labeling · Standard review | Approved | |
| Apr 26, 2006 | Supplement 28Labeling · Standard review | Approved | |
| Apr 26, 2006 | Supplement 26Labeling · Standard review | Approved | |
| Dec 9, 2005 | Supplement 22Labeling · Standard review | Approved | |
| Mar 28, 2005 | Supplement 20Labeling · Standard review | Approved | |
| Dec 6, 2002 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Aug 28, 2002 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 16, 2002 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 23, 2002 | Supplement 12Labeling · Standard review | Approved | |
| Dec 4, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 24, 2001 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 19, 2001 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 21, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2000 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 24, 2000 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jan 23, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 4, 1999 | Supplement 1Labeling · Standard review | Approved | |
| Apr 7, 1998 | Original applicationNew combination · 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
