Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021670
Company: DORC
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
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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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