Drugs@FDA: FDA-Approved Drugs
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TOPICORT | DESOXIMETASONE | 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
02/28/1977 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
09/15/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/26/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1993 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/27/2004 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17856slr024,18309slr013ltr.pdf | |
11/08/1988 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/19/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/25/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/07/1983 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/08/1982 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/20/1981 | SUPPL-13 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
08/20/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/06/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
10/09/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/1979 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/23/1979 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/22/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/23/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/03/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
06/30/1978 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
10/21/1977 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/27/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17856slr024,18309slr013_topicort_lbl.pdf |