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): 210721
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 25MG | CAPSULE;ORAL | Prescription |
AB1 |
No | No |
| CYCLOSPORINE | CYCLOSPORINE | 50MG | CAPSULE;ORAL | Prescription |
AB1 |
No | No |
| CYCLOSPORINE | CYCLOSPORINE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/10/2019 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CYCLOSPORINE
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 |
CAPSULE;ORAL; 50MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOSPORINE | CYCLOSPORINE | 50MG | CAPSULE;ORAL | Prescription | No | AB1 | 210721 | APOTEX |
| CYCLOSPORINE | CYCLOSPORINE | 50MG | CAPSULE;ORAL | Prescription | No | AB1 | 065110 | IVAX SUB TEVA PHARMS |
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 |
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