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 TARO
Abbreviated New Drug Application (ANDA): 075279
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;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 |
|---|---|---|---|---|---|---|---|
| 05/28/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75279ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/23/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CLOBETASOL PROPIONATE
GEL;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% | GEL;TOPICAL | Prescription | No | AB | 075368 | FOUGERA PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 075027 | PADAGIS US |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 075279 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 208881 | TELIGENT |
| EMBELINE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 076141 | AKORN |
منبع : www.accessdata.fda.gov
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