Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 186MG | 1 | CRESEMBA | ISAVUCONAZONIUM SULFATE |
| 002 | CAPSULE;ORAL | 74.5MG | 1 | CRESEMBA | ISAVUCONAZONIUM SULFATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-03-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-01-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2019-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2021-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2021-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2022-02-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 11 | Null | 31 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 207500
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"CRESEMBA","activeIngredients":"ISAVUCONAZONIUM SULFATE","strength":"186MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207500s005,207501s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207500s001,207501s001lbl.pdf\"}]","notes":"Please see"},{"actionDate":"04\/03\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207500s001,207501s001lbl.pdf\"}]","notes":"Please see"},{"actionDate":"03\/06\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207500Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/06\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207500Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207500Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207500Orig1207501Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207500Orig1207501Orig1s000Lbl.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/09\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207500s005,207501s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207500Orig1s005,207501Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/05\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/03\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207500s001,207501s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207500Orig1s001,207501Orig1s001ltr.pdf\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."}]
[actionDate] => 2019-12-09
)
)