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 AMNEAL
Abbreviated New Drug Application (ANDA): 210046
Company: AMNEAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
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 |
---|---|---|---|---|---|---|---|
05/25/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
CYCLOPHOSPHAMIDE
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210046 | AMNEAL |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040745 | BAXTER HLTHCARE |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204555 | JIANGSU HENGRUI MED |
INJECTABLE;INJECTION; 1GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210046 | AMNEAL |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040745 | BAXTER HLTHCARE |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204555 | JIANGSU HENGRUI MED |
INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210046 | AMNEAL |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 040745 | BAXTER HLTHCARE |
CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 204555 | JIANGSU HENGRUI MED |
منبع : www.accessdata.fda.gov
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