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
CYTARABINE از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 075383
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 100MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 11/22/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75383ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2019 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/03/2018 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/28/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/17/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 100MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076512 | FRESENIUS KABI USA |
| CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075383 | HOSPIRA |
| CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 205696 | MEITHEAL |
| CYTARABINE | CYTARABINE | 100MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201784 | MYLAN LABS LTD |
منبع : www.accessdata.fda.gov
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