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 از شرکت TEVA
Abbreviated New Drug Application (ANDA): 073306
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 02/28/1995 | 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 |
|---|---|---|---|---|---|
| 12/20/2002 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/29/2002 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/04/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/2000 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/28/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLOTRIMAZOLE
SOLUTION;TOPICAL; 1%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 209815 | NOVITIUM PHARMA |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 074580 | TARO |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 212281 | TASMAN PHARMA |
| CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | SOLUTION;TOPICAL | Prescription | No | AT | 073306 | TEVA |
منبع : www.accessdata.fda.gov
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