TISSUEBLUE

Registrants (1)

DUNS Number

407522184

Labeler

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Registrant

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

DUNS Number

340805167

NDC Product Code

68803-722

Application Number

NDA209569

Marketing Category

NDA (C73594)

Route of Administration

INTRAOCULAR, OPHTHALMIC

Effective Date

October 5, 2023

Ingredients

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACTQuantity: 8.2 mg in 0.5 mL

SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATEInactive

Code: E1W4N241FOClass: IACTQuantity: 3.1 mg in 0.5 mL

WATERInactive

Code: 059QF0KO0RClass: IACTQuantity: 4743 g in 0.5 mL

SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive

Code: 5QWK665956Class: IACTQuantity: 0.3 mg in 0.5 mL

Code: M1ZRX790SIClass: ACTIBQuantity: 0.0125 mg in 0.5 mL

POLYETHYLENE GLYCOL 3350Inactive

Code: G2M7P15E5PClass: IACTQuantity: 2 mg in 0.5 mL