Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040374
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMCINOLONE ACETONIDE | TRIAMCINOLONE ACETONIDE | 0.025% | OINTMENT;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/05/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40374_Triamcinolone%20Acetonide_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40374ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/040374_triamcinolone-acetonide_toc.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/40374_Triamcinolone%20Acetonide_Prntlbl.pdf |