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
CRESEMBA از شرکت ASTELLAS
New Drug Application (NDA): 207501
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CRESEMBA | ISAVUCONAZONIUM SULFATE | 372MG | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/2015 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207501Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/22/2021 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s008,207501s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207500Orig1s008; 207501Orig1s007ltr.pdf |
||
| 05/18/2021 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s006,207501s005lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207500Orig1s006;%20207501Orig1s005ltr.pdf |
||
| 12/09/2019 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207500s005,207501s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207500Orig1s005,207501Orig1s004ltr.pdf |
||
| 04/03/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Patient 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/2015/207500s001,207501s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/18/2021 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s006,207501s005lbledt.pdf | |
| 04/22/2021 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s008,207501s007lbl.pdf | |
| 12/09/2019 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207500s005,207501s004lbl.pdf | |
| 04/03/2015 | SUPPL-1 |
Labeling-Container/Carton Labels |
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/2015/207500s001,207501s001lbl.pdf |
| 04/03/2015 | SUPPL-1 |
Labeling-Patient 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/2015/207500s001,207501s001lbl.pdf |
| 03/06/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207501Orig1s000lbl.pdf |
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