Home Applications 209569 Application 209569
Type NDA
Sponsor DUTCH OPHTHALMIC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TISSUEBLUE BRILLIANT BLUE G SOLUTION;OPHTHALMIC 0.025% 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 N209569-001 TISSUEBLUE BRILLIANT BLUE G 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209569-001 ODE-282 2026-12-20
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 2026-09-14 22:38:34 2026-08 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209569-001 TISSUEBLUE 0.025% SOLUTION / OPHTHALMIC RLD, RS 2019-12-20 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TISSUEBLUE BRILLIANT BLUE G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. 9d4b28b4-c582-4e2c-abd9-f7e203378e2d 2026-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 209569 application number: NDA209569 ndc (product): 68803-722
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68803-722 TISSUEBLUE Brilliant Blue G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. NDA Current 68803-722 TISSUEBLUE Brilliant Blue G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. NDA Current 68803-722 TISSUEBLUE Brilliant Blue G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. NDA Current 68803-722 TISSUEBLUE Brilliant Blue G D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 81887 SUPPL 2025-04-08 81830 SUPPL 2025-04-07 70673 SUPPL 2022-03-31 70667 SUPPL 2022-03-31 61550 ORIG 2020-01-10 61401 ORIG 2019-12-23 61368 ORIG 2019-12-20