Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073210
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOPICORT | DESOXIMETASONE | 0.05% | CREAM;TOPICAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/30/1990 | 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 |
|---|---|---|---|---|---|
| 06/19/2014 | SUPPL-31 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073210Orig1s029Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/073210Orig1s029ltr.pdf | |
| 12/30/2011 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/23/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/19/2004 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/19/2003 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/20/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1996 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 01/11/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/073210Orig1s029Lbl.pdf |
TOPICORT
CREAM;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DESOXIMETASONE | DESOXIMETASONE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 208163 | LUPIN |
| DESOXIMETASONE | DESOXIMETASONE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 210980 | RISING |
| TOPICORT | DESOXIMETASONE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 073210 | TARO |