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 MYLAN
Abbreviated New Drug Application (ANDA): 075338
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;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 |
|---|---|---|---|---|---|---|---|
| 02/09/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75338ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOBETASOL PROPIONATE
CREAM;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% | CREAM;TOPICAL | Prescription | No | AB1 | 213291 | ALEOR DERMACEUTICALS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211256 | AMNEAL |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074139 | COSETTE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 212982 | ENCUBE |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074392 | FOUGERA PHARMS INC |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211207 | GLASSHOUSE PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 209095 | GLENMARK PHARMS |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210208 | LUPIN LTD |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 075338 | MYLAN |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211401 | RISING |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074249 | TARO |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 209974 | TELIGENT |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211836 | TORRENT |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210034 | XIROMED |
| CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211074 | ZYDUS PHARMS |
| CORMAX | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 074220 | AKORN |
منبع : www.accessdata.fda.gov
نظرات کاربران