Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074087
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | 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 |
|---|---|---|---|---|---|---|---|
| 02/16/1994 | 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 |
|---|---|---|---|---|---|
| 11/26/2004 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/31/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/24/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2002 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/23/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/26/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 03/27/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/13/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |