BLA 761104

ASTRAZENECA AB

FDA Drug Application

Application #761104

Documents

• Label: 2018-09-13
• Medication Guide: 2018-09-13
• Letter: 2018-09-14
• Review: 2018-10-11
• Label: 2019-01-29
• Medication Guide: 2019-01-29
• Letter: 2019-02-13
• Label: 2020-08-21
• Medication Guide: 2020-08-21
• Letter: 2020-08-24

Application Sponsors

BLA 761104

ASTRAZENECA AB

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/VIAL

0

LUMOXITI

MOXETUMOMAB PASUDOTOX-TDFK

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-09-13	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2020-08-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761104
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/761104s000lbl.pdf#page=18"]
            [products] => [{"drugName":"LUMOXITI","activeIngredients":"MOXETUMOMAB PASUDOTOX-TDFK","strength":"1MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/25\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761121s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761121s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761104s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/13\/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\\\/761104s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761104Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761104Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/25\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761121s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761104Orig1s001Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-01-25
        )

)