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): 071868
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 |
|---|---|---|---|---|---|---|---|
| 06/04/1990 | 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-32 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf |
||
| 01/15/2019 | SUPPL-31 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/15/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2001 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/18/2000 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/12/2000 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/28/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1995 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/23/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/25/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2020 | SUPPL-32 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/071868s032lbl.pdf |
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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