Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
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ARISTOSPAN | TRIAMCINOLONE HEXACETONIDE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ARISTOSPAN | TRIAMCINOLONE HEXACETONIDE | 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
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 |