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
CERUBIDINE از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 064103
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 02/03/1995 | 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 |
|---|---|---|---|---|---|
| 12/13/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/18/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 09/03/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CERUBIDINE
INJECTABLE;INJECTION; EQ 20MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CERUBIDINE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064103 | WEST-WARD PHARMS INT |
| DAUNORUBICIN HYDROCHLORIDE | DAUNORUBICIN HYDROCHLORIDE | EQ 20MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065000 | FRESENIUS KABI USA |
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