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
CEFOXITIN از شرکت HIKMA FARMACEUTICA
Abbreviated New Drug Application (ANDA): 065238
Company: HIKMA FARMACEUTICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 03/12/2010 | 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 |
|---|---|---|---|---|---|
| 12/30/2019 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/30/2019 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/30/2019 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
CEFOXITIN
INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065414 | ACS DOBFAR |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065238 | HIKMA FARMACEUTICA |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065051 | WEST-WARD PHARMS INT |
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 065214 | B BRAUN |
INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065414 | ACS DOBFAR |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065238 | HIKMA FARMACEUTICA |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065051 | WEST-WARD PHARMS INT |
| CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 065214 | B BRAUN |
حتما بخوانید : ACYCLOVIR از شرکت ACTAVIS MID ATLANTIC
منبع : www.accessdata.fda.gov
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