Home Applications 205388 Application 205388
Type NDA
Sponsor OMEROS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE SOLUTION;IRRIGATION EQ 0.3% BASE;EQ 1% BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N205388-001 OMIDRIA KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205388-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205388-001 9066856 2033-10-23 Drug product 2015-07-13 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 N205388-001 9066856*PED 2034-04-23 Pediatric extension N205388-001 9486406*PED 2034-04-23 Pediatric extension
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 · 42 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 2026-08-18 06:07:40 2026-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205388-001 OMIDRIA EQ 0.3% BASE;EQ 1% BASE SOLUTION / IRRIGATION AT RLD, RS 2014-05-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 12 · 446 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9066856*PED 2034-04-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205388-001 9486406*PED 2034-04-23 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9066856*PED 2034-04-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205388-001 9486406*PED 2034-04-23 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9066856*PED 2034-04-23 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205388-001 9486406*PED 2034-04-23 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9066856*PED 2034-04-23 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205388-001 9486406*PED 2034-04-23 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9066856*PED 2034-04-23 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205388-001 9486406*PED 2034-04-23 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9066856*PED 2034-04-23 Pediatric extension b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205388-001 9486406*PED 2034-04-23 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 8173707*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 8586633*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9278101*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9399040*PED 2024-01-30 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9066856 2033-10-23 Drug product 2015-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9486406 2033-10-23 Drug product 2016-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9855246 2033-10-23 Drug product 2018-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9066856*PED 2034-04-23 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205388-001 9486406*PED 2034-04-23 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205388-001 8173707*PED 2024-01-30 Pediatric extension 2680178bc6a6…
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62225-600 Omidria phenylephrine and ketorolac Omeros Corporation NDA Current 62225-600 Omidria phenylephrine and ketorolac Omeros Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 50778 SUPPL 2017-12-20 50654 SUPPL 2017-12-11 19641 SUPPL 2016-06-24 24493 ORIG 2014-12-09 22986 ORIG 2014-12-09 32666 ORIG 2014-06-03 19640 ORIG 2014-06-03 51555 SUPPL 1900-01-01 51554 SUPPL 1900-01-01 51553 SUPPL 1900-01-01