اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLOBETASOL PROPIONATE از شرکت COSETTE
Abbreviated New Drug Application (ANDA): 074331
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription |
AT |
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. |
CLOBETASOL PROPIONATE
SOLUTION;TOPICAL; 0.05%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 212881 | ALEOR DERMACEUTICALS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 074331 | COSETTE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 075391 | FOUGERA PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 210190 | GLENMARK PHARMS LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 209361 | MACLEODS PHARMS LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 206075 | NOVEL LABS INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 213139 | PRINSTON INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 211494 | SAPTALIS PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 075224 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 075363 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 076977 | TOLMAR |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 075205 | WOCKHARDT BIO AG |
| EMBELINE | CLOBETASOL PROPIONATE | 0.05% | SOLUTION;TOPICAL | Prescription | No | AT | 074222 | AKORN |
منبع : www.accessdata.fda.gov
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