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 PADAGIS US
Abbreviated New Drug Application (ANDA): 090898
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;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 |
|---|---|---|---|---|---|---|---|
| 06/16/2011 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/090898Orig1s000Approv.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/06/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2017 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CLOBETASOL PROPIONATE
SPRAY;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% | SPRAY;TOPICAL | Prescription | No | AT | 211191 | ALEOR DERMACEUTICALS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 209004 | GLENMARK PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208125 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 090898 | PADAGIS US |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 208842 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | No | AT | 206378 | ZYDUS PHARMS |
| CLOBEX | CLOBETASOL PROPIONATE | 0.05% | SPRAY;TOPICAL | Prescription | Yes | AT | 021835 | GALDERMA LABS LP |
منبع : www.accessdata.fda.gov
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