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
CORMAX از شرکت AKORN
Abbreviated New Drug Application (ANDA): 074220
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORMAX | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription |
AB1 |
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 |
|---|---|---|---|---|---|---|---|
| 05/16/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/26/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CORMAX
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