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
CYCLOSPORINE از شرکت IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 065078
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
03/25/2005 | 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 |
---|---|---|---|---|---|
09/24/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/26/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/12/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
SOLUTION;ORAL; 100MG/ML
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | No | AB1 | 065025 | ABBVIE |
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | No | AB1 | 065078 | IVAX SUB TEVA PHARMS |
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | No | AB1 | 065054 | MAYNE PHARMA |
NEORAL | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | Yes | AB1 | 050716 | NOVARTIS |
منبع : www.accessdata.fda.gov
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