Details for New Drug Application (NDA): 209569

NDA 209569 describes TISSUEBLUE, which is a drug marketed by Dutch Ophthalmic and is included in one NDA. It is available from one supplier. Additional details are available on the TISSUEBLUE profile page.

The generic ingredient in TISSUEBLUE is brilliant blue g. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the brilliant blue g profile page.

Summary for 209569

Tradename:	TISSUEBLUE
Applicant:	Dutch Ophthalmic
Ingredient:	brilliant blue g
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209569

Constraining patent/regulatory exclusivity:

INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM)

Dosage:

SOLUTION;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 209569

Mechanism of Action

Dyes

Suppliers and Packaging for NDA: 209569

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TISSUEBLUE	brilliant blue g	SOLUTION;OPHTHALMIC	209569	NDA	D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.	68803-722	68803-722-05	10 POUCH in 1 CARTON (68803-722-05) / 1 SYRINGE, GLASS in 1 POUCH / .5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;OPHTHALMIC			Strength	0.025%
Approval Date:	Dec 20, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 20, 2026
Regulatory Exclusivity Use:	INDICATED TO SELECTIVELY STAIN THE INTERNAL LIMITING MEMBRANE (ILM)

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