Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018763
Company: TARO
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TOPICORT | DESOXIMETASONE | 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/03/1983 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/18/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/19/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/26/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/13/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/27/2004 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18763slr003ltr.pdf | |
02/18/1988 | SUPPL-1 | 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 |
---|---|---|---|---|---|
04/27/2004 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18763slr003_topicort_lbl.pdf |