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
CEFTRIAXONE از شرکت SANDOZ INC
Abbreviated New Drug Application (ANDA): 065204
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription |
AP |
No | Yes |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM 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 |
|---|---|---|---|---|---|---|---|
| 05/03/2005 | 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 |
|---|---|---|---|---|---|
| 09/11/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/13/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
CEFTRIAXONE
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 |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065180 | WOCKHARDT |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | 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 |
|---|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065329 | ACS DOBFAR |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 065204 | SANDOZ INC |
| CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 050796 | B BRAUN |
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