← FDA DRUG APPROVALS

FDA NDA · NDA208073

XIIDRA

lifitegrast

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA208073
TYPE
NDA
ORIGINAL APPROVAL
2016-07-11
LATEST ACTION
2024-04-04
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

XIIDRA · ReferencePrescription
LIFITEGRAST 5% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2024-04-04Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2020-06-04Labeling · Supplement 5 · standard — Label ↗AP
2017-12-17Labeling · Supplement 2 · standard — Letter ↗AP
2016-07-11Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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