Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074139
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/1994 | 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 |
|---|---|---|---|---|---|
| 04/08/2005 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 10/02/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/28/2001 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/31/2002 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/31/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/28/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOBETASOL PROPIONATE
CREAM;TOPICAL; 0.05%
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 213291 | ALEMBIC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211256 | AMNEAL |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075338 | AUROBINDO PHARMA USA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074139 | COSETTE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 212982 | ENCUBE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074392 | FOUGERA PHARMS INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 209095 | GLENMARK PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210208 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211401 | RISING |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074249 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210034 | XIROMED |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211074 | ZYDUS PHARMS |