NDA 217639

STEMLINE THERAPEUTICS INC

FDA Drug Application

Application #217639

Documents

• Label: 2023-01-30
• Letter: 2023-01-30

Application Sponsors

NDA 217639

STEMLINE THERAPEUTICS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	345MG	0	ORSERDU	ELACESTRANT
002	TABLET;ORAL	86MG	0	ORSERDU	ELACESTRANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2023-01-27

PRIORITY

Submissions Property Types

ORIG

1

Null

2

CDER Filings

STEMLINE THERAPEUTICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217639
            [companyName] => STEMLINE THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ORSERDU","activeIngredients":"ELACESTRANT","strength":"345MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ORSERDU","activeIngredients":"ELACESTRANT","strength":"86MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/27\/2023","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/217639s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/27\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2023\\\/217639s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2023\\\/217639Orig1s000correctedltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2023-01-27
        )

)