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 BAXTER HLTHCARE
Abbreviated New Drug Application (ANDA): 040745
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/21/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/040745Orig1s000ChemR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2014 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf |
||
| 06/17/2013 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/25/2014 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040745Orig1s003lbl.pdf |
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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