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
CEFTAZIDIME IN DEXTROSE CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 050823
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTAZIDIME IN DEXTROSE CONTAINER | CEFTAZIDIME | EQ 1GM BASE | INJECTABLE;INJECTION | Prescription |
None |
Yes | No |
| CEFTAZIDIME IN DEXTROSE CONTAINER | CEFTAZIDIME | EQ 2GM BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/2011 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050823s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/050823Orig1s007ltr.pdf |
||
| 05/15/2015 | SUPPL-4 | 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/2015/050823s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050823Orig1s004ltr.pdf |
|
| 04/01/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/29/2019 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050823s007lbl.pdf | |
| 05/15/2015 | SUPPL-4 |
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/2015/050823s004lbl.pdf |
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