Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022223
Company: ALCON RES
Company: ALCON RES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIESENCE | TRIAMCINOLONE ACETONIDE | 40MGML | INJECTABLE; SUSPENSION | Prescription | TBD | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 11/29/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022048s000, 022223s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022048s000_022223s000_TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/29/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf |
TRIESENCE
There are no Therapeutic Equivalents.