Treats persistent (nontransient) erythema of rosacea. ANDA 209158, held by Padagis Israel. Brimonidine Tartrate.
As of Nov 15, 2026, ANDA 209158 (Brimonidine Tartrate), held by Padagis Israel, was first approved by FDA on Sep 23, 2021, with 1 approved supplement and 0 published complete response letters.
Brimonidine topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2021 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Brimonidine TartrateEQ 0.33% BASE · gel;topical | Brimonidine Tartrate | Rx |
| Jun 9, 2022 | Supplement 1Manufacturing | Approved | None posted |
| Sep 23, 2021 | 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
