Active ingredient
Lifitegrast
3 finished FDA listings contain Lifitegrast as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LIFITEGRAST
- Dosage forms
- For Solution, Solution/ Drops
- Routes
- Ophthalmic
- Manufacturers / labelers
- 3
- Strengths listed
- 50 mg/ml
- Brand names in FDA listings
- Xiidra
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1801820
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 208073 | BAUSCH AND LOMB INC | 2016-07-11 | 2 |
| ANDA 215063 | EUGIA PHARMA | 2023-11-07 | 1 |
Official labeling on DailyMed
- XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] · version 6 · 2025-08-20
- XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] · version 5 · 2024-11-25
- LIFITEGRAST FOR SOLUTION [AUROBINDO PHARMA LIMITED] · version 1 · 2023-11-15
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.