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
CEFAZOLIN SODIUM از شرکت ACS DOBFAR
Abbreviated New Drug Application (ANDA): 065306
Company: ACS DOBFAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | No |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 10/22/2008 | 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 |
|---|---|---|---|---|---|
| 12/02/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/13/2013 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/18/2014 | SUPPL-3 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 05/26/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/20/2010 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |
CEFAZOLIN SODIUM
INJECTABLE;INJECTION; EQ 10GM BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065306 | ACS DOBFAR |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065143 | HIKMA FARMACEUTICA |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 209217 | QILU |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |
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