Drugs@FDA: FDA-Approved Drugs
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARISTOCORT | TRIAMCINOLONE DIACETATE | 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
09/05/1961 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf | |
09/04/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/2010 | SUPPL-31 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf | |
08/29/2001 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/25/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/09/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/04/1994 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/07/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
01/06/1992 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/05/1992 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/22/1992 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/1989 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/06/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/17/2003 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf |
01/17/2003 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf |
10/03/1980 | SUPPL-13 | Manufacturing (CMC) |
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-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf | |
01/14/2010 | SUPPL-31 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf |