Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090164
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 40MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 06/01/2009 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/090164s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/090164Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/03/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/13/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/18/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |