BLA 761174

GLAXOSMITHKLINE

FDA Drug Application

Application #761174

Documents

• Label: 2021-04-22
• Medication Guide: 2021-04-22
• Letter: 2021-04-26
• Review: 2021-05-21
• Label: 2022-04-29
• Medication Guide: 2022-04-29
• Letter: 2022-05-02

Application Sponsors

BLA 761174

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/10ML

0

JEMPERLI

DOSTARLIMAB-GXLY

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-04-22	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-04-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761174
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761174s000lbl.pdf#page=20"]
            [products] => [{"drugName":"JEMPERLI","activeIngredients":"DOSTARLIMAB-GXLY","strength":"500MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761174s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761174s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761174Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-22
        )

)