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 ABBVIE
Abbreviated New Drug Application (ANDA): 065025
Company: ABBVIE
| 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 |
|---|---|---|---|---|---|---|---|
| 03/03/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65025ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/06/2015 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2013 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2010 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2009 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2009 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/13/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 02/26/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 02/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/01/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/05/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/26/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/14/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-3 | Bioequivalence |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/05/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |
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