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
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE از شرکت FOUGERA PHARMS
Abbreviated New Drug Application (ANDA): 075502
Company: FOUGERA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 06/05/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75502ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL; EQ 0.05% BASE;1%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 076002 | ACTAVIS MID ATLANTIC |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 075502 | FOUGERA PHARMS |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 202894 | GLENMARK PHARMS |
| CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | No | AB | 075673 | TARO |
| LOTRISONE | BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE | EQ 0.05% BASE;1% | CREAM;TOPICAL | Prescription | Yes | AB | 018827 | MERCK SHARP DOHME |
نظرات کاربران