ANDA 209406, held by Watson Labs Inc. Brinzolamide.
As of Nov 15, 2026, ANDA 209406 (Brinzolamide), held by Watson Labs Inc, was first approved by FDA on Nov 27, 2020, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brinzolamide1% · suspension/drops;ophthalmic | Brinzolamide | Rx |
| Jun 17, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 20, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 27, 2020 | Original application | 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
