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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209569
Company: DUTCH OPHTHALMIC

Products on NDA 209569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TISSUEBLUE	BRILLIANT BLUE G	0.025%	SOLUTION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209569s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209569Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209569Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2025	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209569s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209569Orig1s006ltr.pdf
03/30/2022	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209569Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209569Orig1s004ltr.pdf

Labels for NDA 209569

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2025	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209569s006lbl.pdf
04/04/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209569s006lbl.pdf
03/30/2022	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209569Orig1s004lbl.pdf
12/20/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209569s000lbl.pdf

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