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 (EMOLLIENT) از شرکت FOUGERA PHARMS
Abbreviated New Drug Application (ANDA): 075430
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription |
AB2 |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/26/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75430ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/14/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
CLOBETASOL PROPIONATE (EMOLLIENT)
CREAM;TOPICAL; 0.05%
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075733 | ANI PHARMS |
| CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075430 | FOUGERA PHARMS |
| CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075633 | TARO |
| CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 209411 | TELIGENT |
| EMBELINE E | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075325 | AKORN |
منبع : www.accessdata.fda.gov
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