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
CEFEPIME IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE
New Drug Application (NDA): 050817
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 1GM BASE/50ML (EQ 20MG BASE/ML) | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| CEFEPIME IN PLASTIC CONTAINER | CEFEPIME HYDROCHLORIDE | EQ 2GM BASE/100ML (EQ 20MG BASE/ML) | INJECTABLE;INJECTION | Prescription |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 08/05/2008 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050817s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2020 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050817s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/050817Orig1s008ltr.pdf |
||
| 05/09/2016 | SUPPL-7 | Labeling-Package Insert |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050817s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050817Orig1s007ltr.pdf |
|
| 09/06/2012 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050817Orig1s004ltr.pdf |
||
| 06/04/2014 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050817Orig1s003ltr.pdf |
||
| 06/30/2010 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050817s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/01/2020 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050817s008lbl.pdf | |
| 05/09/2016 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050817s007lbl.pdf |
| 06/04/2014 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050817s003lbl.pdf | |
| 09/06/2012 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050817s004lbl.pdf | |
| 06/30/2010 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050817s001lbl.pdf |
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