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
Abbreviated New Drug Application (ANDA): 065169
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription |
AP |
No | Yes |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription |
AP |
No | Yes |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription |
AP |
No | Yes |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 05/09/2005 | 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 |
|---|---|---|---|---|---|
| 03/05/2016 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2016 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/05/2014 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065169Orig1s022ltr.pdf |
||
| 07/13/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/24/2010 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/05/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 01/14/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/05/2014 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf |
CEFTRIAXONE
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 250MG 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 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | AKORN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 091049 | ASTRAL |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065125 | LUPIN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 500MG 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 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | AKORN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 091049 | ASTRAL |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065125 | LUPIN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 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;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | AKORN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 091049 | ASTRAL |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065125 | LUPIN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 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;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065305 | AKORN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 091049 | ASTRAL |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065342 | HIKMA FARMACEUTICA |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065125 | LUPIN |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 203702 | QILU |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065169 | SANDOZ |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Prescription | No | AP | 065391 | WOCKHARDT |
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