Home Applications 022184 Application 022184
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUMIGAN BIMATOPROST SOLUTION/DROPS;OPHTHALMIC 0.01% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N022184-001 LUMIGAN BIMATOPROST 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022184-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022184-001 7851504 2027-06-13 Drug substance, Drug product
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC AB RLD, RS 2010-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022184-001 LUMIGAN 0.01% SOLUTION/DROPS / OPHTHALMIC RLD, RS 2010-08-31 f41ea6bd6efb…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 13 · 511 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022184-001 7851504 2027-06-13 Drug substance, Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022184-001 7851504 2027-06-13 Drug substance, Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022184-001 7851504 2027-06-13 Drug substance, Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8278353 2025-03-16 Drug product 2012-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8299118 2025-03-16 U-1295 2012-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8309605 2025-03-16 U-1293 2012-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8309605 2025-03-16 U-1294 2012-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8338479 2025-03-16 U-1295 Drug product 2012-12-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8524777 2025-03-16 U-1235 2013-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8586630 2025-03-16 U-1458 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8772338 2025-03-16 U-1528 Drug product 2014-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8933120 2025-03-16 Drug product 2015-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 8933127 2025-03-16 Drug product 2015-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 9155716 2025-03-16 U-1528 Drug product 2015-11-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 9241918 2025-03-16 U-1814 Drug product 2016-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022184-001 7851504 2027-06-13 Drug substance, Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022184-001 8278353 2025-03-16 Drug product 2012-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8299118 2025-03-16 U-1295 2012-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8309605 2025-03-16 U-1293 2012-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8309605 2025-03-16 U-1294 2012-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8338479 2025-03-16 U-1295 Drug product 2012-12-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8524777 2025-03-16 U-1235 2013-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8586630 2025-03-16 U-1458 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8772338 2025-03-16 U-1528 Drug product 2014-07-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8933120 2025-03-16 Drug product 2015-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 8933127 2025-03-16 Drug product 2015-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 9155716 2025-03-16 U-1528 Drug product 2015-11-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 9241918 2025-03-16 U-1814 Drug product 2016-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022184-001 7851504 2027-06-13 Drug substance, Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8278353 2025-03-16 Drug product 2012-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8299118 2025-03-16 U-1295 2012-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8309605 2025-03-16 U-1293 2012-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8309605 2025-03-16 U-1294 2012-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8338479 2025-03-16 U-1295 Drug product 2012-12-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8524777 2025-03-16 U-1235 2013-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8586630 2025-03-16 U-1458 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8772338 2025-03-16 U-1528 Drug product 2014-07-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8933120 2025-03-16 Drug product 2015-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 8933127 2025-03-16 Drug product 2015-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022184-001 9155716 2025-03-16 U-1528 Drug product 2015-11-12 fd3edfee7708…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-3205 LUMIGAN bimatoprost Allergan, Inc. NDA Current 0023-3205 LUMIGAN bimatoprost Allergan, Inc. NDA Current 0023-3205 LUMIGAN bimatoprost Allergan, Inc. NDA Current