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 PADAGIS US
Abbreviated New Drug Application (ANDA): 065151
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 10/07/2003 | 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 |
|---|---|---|---|---|---|
| 06/30/2015 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/10/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/24/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065151 | PADAGIS US |
| CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065004 | WEST-WARD PHARMS INT |
| SANDIMMUNE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050573 | NOVARTIS |
منبع : www.accessdata.fda.gov
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