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FDA Product

VISIONBLUE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

VISIONBLUE

68803-612

Regulatory Information

68803-612

NDA021670

C73594

October 5, 2023

USA

VisionBlue® 0.06% Trypan blue Ophthalmic Solution. These highlights do not include all the information needed to use VISIONBLUE® 0.06% safely and effectively. see full prescribing information for VISIONBLUE® 0.06%. VisionBlue® (trypan blue ophthalmic solution) 0.06% Initial U.S. Approval: 2004

HUMAN PRESCRIPTION DRUG LABEL

20

Company Information

Active Ingredients

TRYPAN BLUE

Quantity: 0.3 mg in 0.5 mL

Code: I2ZWO3LS3M

Class Code: ACTIB

SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

Quantity: 0.15 mg in 0.5 mL

Code: 5QWK665956

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, DIHYDRATE

Quantity: 0.85 mg in 0.5 mL

Code: 94255I6E2T

Class Code: IACT

SODIUM CHLORIDE

Quantity: 4.1 mg in 0.5 mL

Code: 451W47IQ8X

Class Code: IACT

WATER

Quantity: 0.5 mL in 0.5 mL

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

TRYPAN BLUE FREE ACID

Code: 768N7QO4KH

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