Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021670
Company: DORC
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 |
---|---|---|---|---|---|
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 |
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 |