BLA 761116

STEMLINE THERAPEUTICS INC

FDA Drug Application

Application #761116

Documents

• Label: 2018-12-21
• Review: 2019-01-28
• Letter: 2022-10-28
• Label: 2022-10-28
• Letter: 2022-11-04
• Label: 2022-11-07

Application Sponsors

BLA 761116

STEMLINE THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INJECTION

1000MCG

0

ELZONRIS

TAGRAXOFUSP-ERZS

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-12-21	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2022-10-27	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-11-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	15

CDER Filings

STEMLINE THERAPEUTICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761116
            [companyName] => STEMLINE THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELZONRIS","activeIngredients":"TAGRAXOFUSP-ERZS","strength":"1000MCG","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761116s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761116s000lbl.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761116Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-12-21
        )

)