Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011685
Company: FOSUN PHARMA
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARISTOCORT | TRIAMCINOLONE DIACETATE | 25MG/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 |
---|---|---|---|---|---|---|---|
03/12/1959 | 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-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011685s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011685Orig1s027ltr.pdf | |
07/03/2014 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011685Orig1s026ltr.pdf | |
08/29/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/25/1999 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/09/1995 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/04/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/07/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
02/06/1992 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/05/1992 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/06/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/06/1980 | SUPPL-12 | Manufacturing (CMC)-Formulation |
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-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011685s027lbl.pdf | |
07/03/2014 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf |