ANDA 215126, held by Sun Pharm Inds Ltd. Lifitegrast.
As of Nov 15, 2026, ANDA 215126 (Lifitegrast), held by Sun Pharm Inds Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 11, 2023 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lifitegrast5% ยท solution/drops;ophthalmic | Lifitegrast | None (tentative approval) |
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