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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021670
Company: DORC

Products on NDA 021670

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VISIONBLUE	TRYPAN BLUE	0.06%	SOLUTION;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021670

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021670lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021670ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-670_VisionBlue.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021670s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021670Orig1s011ltr.pdf
04/17/2015	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/25/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
11/21/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021670s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021670Orig1s005ltr.pdf

Labels for NDA 021670

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021670s011lbl.pdf
12/18/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021670s011lbl.pdf
11/21/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021670s005lbl.pdf
12/16/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021670lbl.pdf

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