Home Applications 218424 Application 218424
Type NDA
Sponsor BAUSCH AND LOMB Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUMIFY PRESERVATIVE FREE BRIMONIDINE TARTRATE SOLUTION/DROPS;OPHTHALMIC 0.025% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218424-001 LUMIFY PRESERVATIVE FREE BRIMONIDINE TARTRATE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218424-001 11596600 2029-07-27 U-2222 2024-05-17 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 N218424-001 9259425 2030-07-14 U-2222 2024-05-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218424-001 LUMIFY PRESERVATIVE FREE 0.025% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2024-04-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218424-001 8293742 2030-07-14 U-2222 2024-05-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218424-001 9259425 2030-07-14 U-2222 2024-05-17 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218424-001 11596600 2029-07-27 U-2222 2024-05-17 a50c72e98297…
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 81919 ORIG 2025-04-10 78196 ORIG 2024-04-22 78195 ORIG 2024-04-22