ANDA 216361, held by Dr Reddys Labs SA. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 216361 (Brimonidine Tartrate), held by Dr Reddys Labs SA, was first approved by FDA on Feb 16, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine Tartrate0.025% · solution/drops;ophthalmic | Brimonidine Tartrate | OTC |
| Feb 11, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 16, 2024 | 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
