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
CYCLOPHOSPHAMIDE از شرکت STI PHARMA LLC
Abbreviated New Drug Application (ANDA): 209872
Company: STI PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription |
AB |
No | No |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 05/07/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CYCLOPHOSPHAMIDE
CAPSULE;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 207014 | ANI PHARMS |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 211608 | CIPLA |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription | Yes | AB | 203856 | HIKMA |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription | No | AB | 209872 | STI PHARMA LLC |
CAPSULE;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 207014 | ANI PHARMS |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 211608 | CIPLA |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription | Yes | AB | 203856 | HIKMA |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription | No | AB | 209872 | STI PHARMA LLC |
منبع : www.accessdata.fda.gov
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