Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074248
Company: SUN PHARMA CANADA
Company: SUN PHARMA CANADA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 07/12/1996 | 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 |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/07/2003 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/11/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/2000 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOBETASOL PROPIONATE
OINTMENT;TOPICAL; 0.05%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211800 | ALEMBIC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075057 | AUROBINDO PHARMA USA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074089 | COSETTE PHARMS NC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211295 | ENCUBE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074407 | FOUGERA PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 215990 | MACLEODS PHARMS LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208841 | NOVEL LABS INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074248 | SUN PHARMA CANADA |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 209701 | XIROMED |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210199 | ZYDUS PHARMS |