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): 072945
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 20MG/ML | 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 |
---|---|---|---|---|---|---|---|
02/28/1994 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2020 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
01/15/2019 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/03/2018 | SUPPL-22 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/03/2018 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
11/18/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
05/14/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
08/08/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/18/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/12/2000 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
06/03/1997 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
04/28/1995 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
09/21/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 20MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206189 | HONG KONG |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071868 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072168 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 072945 | HOSPIRA |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206190 | MEITHEAL |
CYTARABINE | CYTARABINE | 20MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 200915 | MYLAN LABS LTD |
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