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 APOTEX
Abbreviated New Drug Application (ANDA): 065040
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription |
AB2 |
No | No |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription |
AB2 |
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 |
|---|---|---|---|---|---|---|---|
| 05/09/2002 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65040ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/26/2014 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/08/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
CAPSULE;ORAL; 25MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | No | AB2 | 065040 | APOTEX |
| SANDIMMUNE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 050625 | NOVARTIS |
CAPSULE;ORAL; 100MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | No | AB2 | 065040 | APOTEX |
| SANDIMMUNE | CYCLOSPORINE | 100MG | CAPSULE;ORAL | Prescription | Yes | AB2 | 050625 | NOVARTIS |
منبع : www.accessdata.fda.gov
نظرات کاربران