Documents
Application Sponsors
| NDA 208562 | XELLIA PHARMS APS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | POWDER;INTRAVENOUS | 200MG/VIAL | 0 | VORICONAZOLE | VORICONAZOLE |
| 002 | INJECTABLE;INJECTION | 200MG | 2 | VORICONAZOLE | VORICONAZOLE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-03-09 | STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-03-26 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2021-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2023-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-08-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 7 |
TE Codes
CDER Filings
XELLIA PHARMS APS
cder:Array
(
[0] => Array
(
[ApplNo] => 208562
[companyName] => XELLIA PHARMS APS
[docInserts] => ["",""]
[products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"03\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208562s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/09\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208562s000lbl.pdf\"}]","notes":"Please see"}]
[originalApprovals] => [{"actionDate":"03\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208562s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208562Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208562Orig1s000TOC.cfm\"}]","notes":"> Please see www.fda.gov\/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs."}]
[supplements] => [{"actionDate":"03\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208562s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208562s002ltr.pdf\"}]","notes":">"}]
[actionDate] => 2018-03-26
)
)