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 HIKMA FARMACEUTICA
Abbreviated New Drug Application (ANDA): 065047
Company: HIKMA FARMACEUTICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2001 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65047ltr.pdf |
CEFAZOLIN SODIUM
INJECTABLE;INJECTION; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065303 | ACS DOBFAR |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065047 | HIKMA FARMACEUTICA |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |
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 |
|---|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065303 | ACS DOBFAR |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065047 | HIKMA FARMACEUTICA |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 203661 | QILU |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 062831 | SANDOZ |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065345 | SANDOZ |
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