Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016466
Company: ETHYPHARM
Company: ETHYPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARISTOSPAN | TRIAMCINOLONE HEXACETONIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ARISTOSPAN | TRIAMCINOLONE HEXACETONIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/29/1969 | ORIG-1 | Approval | Type 2 - New Active Ingredient | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016466s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/016466Orig1s047ltr.pdf | |
| 07/03/2014 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016466Orig1s046ltr.pdf | |
| 09/04/2014 | SUPPL-45 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/016466Orig1s045.pdf |
| 06/03/2009 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf | |
| 06/03/2009 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/016466s040s041ltr.pdf | |
| 03/01/2007 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016466s036ltr.pdf | |
| 02/12/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/016466Orig1s032.pdf |
| 10/25/1999 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1995 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1994 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/01/2006 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/016466s027ltr.pdf | |
| 09/07/1993 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1991 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1990 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1985 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/07/1980 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1978 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/13/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/05/2024 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/016466s047lbl.pdf | |
| 07/03/2014 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/016466s046lbl.pdf | |
| 06/03/2009 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf | |
| 06/03/2009 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016466s040s041lbl.pdf | |
| 03/01/2007 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016466s036lbl.pdf | |
| 02/01/2006 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/016466s027lbl.pdf |