Home Applications 022369 Application 022369
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LATISSE BIMATOPROST SOLUTION/DROPS;TOPICAL 0.03% 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 N022369-001 LATISSE BIMATOPROST 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022369-001 AT
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022369-001 LATISSE 0.03% SOLUTION/DROPS / TOPICAL AT RLD, RS 2008-12-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 265 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 9216183 2023-01-15 U-1487 2016-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 9226931 2023-01-15 U-1799 2016-01-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8038988 2023-08-25 U-1208 Drug substance, Drug product 2011-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 9216183 2023-01-15 U-1487 2016-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 9226931 2023-01-15 U-1799 2016-01-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8038988 2023-08-25 U-1208 Drug substance, Drug product 2011-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8101161 2024-05-25 U-1218 2012-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022369-001 8101161 2024-05-25 U-1217 2012-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022369-001 8263054 2023-01-15 U-1277 2012-09-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8632760 2023-01-15 U-1487 2014-02-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8758733 2023-01-15 U-1487 2014-07-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022369-001 8986715 2023-01-15 U-1217 2015-04-01 4b0b4de00fa7…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0023-3616 LATISSE bimatoprost Allergan, Inc. NDA Current 0023-3616 LATISSE bimatoprost Allergan, Inc. NDA Current 0023-3616 LATISSE bimatoprost Allergan, Inc. NDA Current 0023-3616 LATISSE bimatoprost Allergan, Inc. NDA Current