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): 074245
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 1GM/VIAL | INJECTABLE;INJECTION | Prescription |
None |
No | Yes |
| CYTARABINE | CYTARABINE | 2GM/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1994 | 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 |
|---|---|---|---|---|---|
| 10/13/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/27/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYTARABINE
INJECTABLE;INJECTION; 2GM/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYTARABINE | CYTARABINE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 211938 | GLAND PHARMA LTD |
| CYTARABINE | CYTARABINE | 2GM/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 074245 | WEST-WARD PHARMS INT |
منبع : www.accessdata.fda.gov
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