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 WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 071471
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 100MG/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1989 | 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 |
|---|---|---|---|---|---|
| 06/18/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/13/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/21/1995 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/17/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/18/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 100MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211937 | GLAND PHARMA LTD |
| CYTARABINE | CYTARABINE | 100MG/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 071471 | WEST-WARD PHARMS INT |
منبع : www.accessdata.fda.gov
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