ANDA 215081, held by Micro Labs. Lifitegrast.
As of Nov 15, 2026, ANDA 215081 (Lifitegrast), held by Micro Labs, was first approved by FDA on Aug 4, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 4, 2023 | 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
