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
CEFUROXIME SODIUM از شرکت WATSON LABS INC
Abbreviated New Drug Application (ANDA): 064036
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 7.5GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 02/26/1993 | 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 |
|---|---|---|---|---|---|
| 12/08/2000 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/26/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/20/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/04/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 07/03/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1994 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/15/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
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