BLA 761128

NOVARTIS PHARMS CORP

FDA Drug Application

Application #761128

Documents

• Label: 2019-11-15
• Letter: 2019-11-19
• Review: 2019-12-17
• Letter: 2021-07-14
• Label: 2021-07-14
• Letter: 2022-09-09
• Label: 2022-09-10

Application Sponsors

BLA 761128

NOVARTIS PHARMS CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

100MG/10ML

0

ADAKVEO

CRIZANLIZUMAB-TMCA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-11-15	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2022-09-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	6

CDER Filings

NOVARTIS PHARMS CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761128
            [companyName] => NOVARTIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADAKVEO","activeIngredients":"CRIZANLIZUMAB-TMCA","strength":"100MG\/10ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761128s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761128s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761128Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761128Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-11-15
        )

)