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 SANDOZ
Abbreviated New Drug Application (ANDA): 065017
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription |
AB1 |
No | No |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/13/2000 | ORIG-1 | Approval |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine_prntlbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/04/2016 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2013 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/06/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/19/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/19/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/06/2001 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/13/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/65017a_Cyclosporine_prntlbl.pdf |
CYCLOSPORINE
CAPSULE;ORAL; 100MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 210721 | APOTEX |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065110 | IVAX SUB TEVA PHARMS |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065044 | MAYNE PHARMA |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065017 | SANDOZ |
| GENGRAF | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB1 | 065003 | ABBVIE |
| NEORAL | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB1 | 050715 | NOVARTIS |
CAPSULE;ORAL; 25MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 210721 | APOTEX |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065110 | IVAX SUB TEVA PHARMS |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065044 | MAYNE PHARMA |
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065017 | SANDOZ |
| GENGRAF | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB1 | 065003 | ABBVIE |
| NEORAL | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB1 | 050715 | NOVARTIS |
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