Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074331
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 12/15/1995 | 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 |
|---|---|---|---|---|---|
| 03/11/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/15/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |