Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022278
Company: DORC
Company: DORC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEMBRANEBLUE | TRYPAN BLUE | 0.15% | SOLUTION;OPHTHALMIC | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/20/2009 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022278s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022278_membraneblue_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/15/2014 | SUPPL-3 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022278Orig1s003ltr.pdf | |
08/25/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/15/2014 | SUPPL-3 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022278s003lbl.pdf | |
02/20/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022278lbl.pdf |