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 ANI PHARMS
Abbreviated New Drug Application (ANDA): 075733
Company: ANI 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 | 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 |
---|---|---|---|---|---|---|---|
08/22/2001 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75733_Clobetasol Propionate_Prntlbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/22/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75733_Clobetasol Propionate_Prntlbl.pdf |
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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