Home Applications 022278 Application 022278
Type NDA
Sponsor DORC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEMBRANEBLUE TRYPAN BLUE SOLUTION;OPHTHALMIC 0.15% 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 N022278-001 MEMBRANEBLUE TRYPAN BLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20
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.
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 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD 2009-02-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022278-001 MEMBRANEBLUE 0.15% SOLUTION / OPHTHALMIC RLD, RS 2009-02-20 cb3db0bc1861…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022278-001 6696430 2019-05-07 U-2377 2018-09-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022278-001 6372449 2019-11-12 U-2379 2018-09-06 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022278-001 6696430 2019-05-07 U-2377 2018-09-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022278-001 6372449 2019-11-12 U-2379 2018-09-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022278-001 6696430 2019-05-07 U-2377 2018-09-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022278-001 6372449 2019-11-12 U-2379 2018-09-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022278-001 6696430 2019-05-07 U-2377 2018-09-06 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022278-001 6372449 2019-11-12 U-2379 2018-09-06 ea99ee380514…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68803-672 MEMBRANEBLUE trypan blue Dutch Ophthalmic Research Center (International) B.V. NDA Current 68803-672 MEMBRANEBLUE trypan blue Dutch Ophthalmic Research Center (International) B.V. NDA Current 68803-672 MEMBRANEBLUE trypan blue Dutch Ophthalmic Research Center (International) B.V. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84199 SUPPL 2025-11-18 84189 SUPPL 2025-11-18 38493 SUPPL 2014-09-19 7163 SUPPL 2014-09-17 21980 ORIG 2009-12-16 38492 ORIG 2009-02-24 7162 ORIG 2009-02-24