NDA 217415

XELLIA PHARMS APS

FDA Drug Application

Application #217415

Documents

• Letter: 2023-01-31
• Label: 2023-01-31

Application Sponsors

NDA 217415

XELLIA PHARMS APS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER	350MG	0	DAPTOMYCIN	DAPTOMYCIN
002	POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER	500MG	0	DAPTOMYCIN	DAPTOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2023-01-30

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217415
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"350MG","dosageForm":"POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"DAPTOMYCIN","activeIngredients":"DAPTOMYCIN","strength":"500MG","dosageForm":"POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/30\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/217415Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2023","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\\\/2023\\\/217415Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/217415Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-30
        )

)