ANDA 215058, held by Ingenus Pharms LLC. Lifitegrast.
As of Nov 15, 2026, ANDA 215058 (Lifitegrast), held by Ingenus Pharms LLC, was first approved by FDA on Oct 3, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lifitegrast5% ยท solution/drops;ophthalmic | Lifitegrast | Discontinued |
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
