BLA 761196

ADC Therapeutics SA

FDA Drug Application

Application #761196

Documents

• Label: 2021-04-23
• Letter: 2021-04-27
• Review: 2021-05-24
• Letter: 2022-10-13
• Letter: 2022-10-13
• Label: 2022-10-17
• Label: 2022-10-17

Application Sponsors

BLA 761196

ADC Therapeutics SA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG

0

ZYNLONTA

LONCASTUXIMAB TESIRINE-LPYL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-04-23	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2022-10-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-10-12	STANDARD

Submissions Property Types

ORIG	1	Null	23
SUPPL	4	Null	15
SUPPL	5	Null	6

CDER Filings

ADC Therapeutics SA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761196
            [companyName] => ADC Therapeutics SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYNLONTA","activeIngredients":"LONCASTUXIMAB TESIRINE-LPYL","strength":"10MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761196s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761196s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761196Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-23
        )

)