Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074286
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPICORT | DESOXIMETASONE | 0.25% | OINTMENT;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/07/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/074286Orig1s017ltr.pdf | |
| 03/15/2010 | SUPPL-16 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/074286Orig1s016.pdf |
| 04/15/2015 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/25/2008 | SUPPL-13 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s013.pdf |
| 07/25/2008 | SUPPL-12 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/074286Orig1s012.pdf |
| 09/15/2005 | SUPPL-10 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/074286Orig1s010.pdf |
| 11/23/2004 | SUPPL-9 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s009.pdf |
| 04/26/2004 | SUPPL-8 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s008.pdf |
| 04/26/2004 | SUPPL-7 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/074286Orig1s007.pdf |
| 12/19/2003 | SUPPL-6 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/074286Orig1s006.pdf |
| 05/16/2000 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/074286Orig1s004.pdf |
| 04/09/1999 | SUPPL-3 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/074286Orig1s003.pdf |
| 07/18/1997 | SUPPL-2 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/074286Orig1s002.pdf |
| 09/17/1996 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1996/074286Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/20/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/074286Orig1s017lbl.pdf |