Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089472
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| U-CORT | HYDROCORTISONE ACETATE | 1% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 06/13/1988 | 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 |
|---|---|---|---|---|---|
| 06/17/2013 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 06/07/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/04/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |