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 ACS DOBFAR SPA
Abbreviated New Drug Application (ANDA): 064125
Company: ACS DOBFAR SPA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription |
AB |
No | No |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/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 |
|---|---|---|---|---|---|---|---|
| 05/30/1997 | 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 |
|---|---|---|---|---|---|
| 04/12/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/21/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/31/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/23/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/23/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CEFUROXIME SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AB | 064125 | ACS DOBFAR SPA |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AB | 065048 | HIKMA FARMACEUTICA |
| ZINACEF | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | Yes | AB | 050558 | TELIGENT |
INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050780 | B BRAUN |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 064125 | ACS DOBFAR SPA |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065048 | HIKMA FARMACEUTICA |
| ZINACEF | CEFUROXIME SODIUM | EQ 1.5GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050558 | TELIGENT |
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