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 HIKMA
New Drug Application (NDA): 203856
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 25MG | CAPSULE;ORAL | Prescription |
AB |
Yes | No |
| CYCLOPHOSPHAMIDE | CYCLOPHOSPHAMIDE | 50MG | CAPSULE;ORAL | Prescription |
AB |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/2013 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/26/2019 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203856Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/26/2019 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203856s003lbl.pdf | |
| 09/16/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203856s000lbl.pdf |
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 |
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