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 PERRIGO ISRAEL
Abbreviated New Drug Application (ANDA): 077763
Company: PERRIGO ISRAEL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription |
AB1 |
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 |
|---|---|---|---|---|---|---|---|
| 03/10/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077763s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/14/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/14/2019 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL; 0.05%
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 210809 | GLENMARK PHARMS LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 206805 | INGENUS PHARMS LLC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 077763 | PERRIGO ISRAEL |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | No | AB1 | 208779 | TARO |
| OLUX | CLOBETASOL PROPIONATE | 0.05% | AEROSOL, FOAM;TOPICAL | Prescription | Yes | AB1 | 021142 | MYLAN |
منبع : www.accessdata.fda.gov
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