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FDA NDA · NDA208144

LUMIFY REDNESS RELIEVER EYE DROPS

brimonidine tartrate

Sponsor: BAUSCH AND LOMB INC

APPLICATION
NDA208144
TYPE
NDA
ORIGINAL APPROVAL
2017-12-22
LATEST ACTION
2024-02-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

LUMIFY · ReferenceOver-the-counter
BRIMONIDINE TARTRATE 0.025% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2024-02-28Labeling · Supplement 17 · standard — Label ↗AP
2023-05-02Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2021-11-29Labeling · Supplement 13 · standard — Letter ↗AP
2020-09-23Labeling · Supplement 11 · standard — Letter ↗AP
2020-03-05Labeling · Supplement 6 · standard — Label ↗AP
2019-04-30Labeling · Supplement 2 · standard — Letter ↗AP
2019-02-21Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2017-12-22Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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