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 FOUGERA PHARMS
Abbreviated New Drug Application (ANDA): 075391
Company: FOUGERA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 02/08/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75391ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-12 | Labeling-Package Insert |
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
نظرات کاربران