Application 209569

Type
NDA
Sponsor
DUTCH OPHTHALMIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TISSUEBLUEBRILLIANT BLUE GSOLUTION;OPHTHALMIC0.025%YesYes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209569-001TISSUEBLUEBRILLIANT BLUE G0.025%SOLUTION / OPHTHALMICRLD, RS2019-12-20

Orange Book exclusivity#

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209569-001ODE-2822026-12-20

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TISSUEBLUEBRILLIANT BLUE GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.9d4b28b4-c582-4e2c-abd9-f7e203378e2d2026-04-17Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

Warnings and Precautions Excessive Staining Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the Syringe Make sure the plunger moves smoothly before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula. Excessive staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining. Use of the syringe: Make sure the plunger moves smoothly before injecting the solution.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Adverse Reactions Adverse reactions that have been reported in procedures that included the use of Brilliant Blue G Ophthalmic Solution have often been associated with the surgical procedure. These complications include retinal (retinal break, tear, hemorrhage, and detachment) and cataracts. Adverse reactions that have been reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. The complications include retinal (retinal break, tear, hemorrhage, and detachment and cataracts. To report SUSPECTED ADVERSE REACTIONS, contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68803-722TISSUEBLUEBrilliant Blue GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NDACurrent
68803-722TISSUEBLUEBrilliant Blue GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NDACurrent
68803-722TISSUEBLUEBrilliant Blue GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NDACurrent
68803-722TISSUEBLUEBrilliant Blue GD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81887SUPPL 2025-04-08
81830SUPPL 2025-04-07
70673SUPPL2022-03-31
70667SUPPL2022-03-31
61550ORIG2020-01-10
61401ORIG2019-12-23
61368ORIG2019-12-20