BLA 761228

IMMUNOCORE LTD

FDA Drug Application

Application #761228

Documents

• Label: 2022-01-26
• Letter: 2022-01-27
• Review: 2022-02-23
• Letter: 2022-11-30
• Label: 2022-12-01

Application Sponsors

BLA 761228

IMMUNOCORE LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MCG/0.5ML

0

KIMMTRAK

TEBENTAFUSP-TEBN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2022-01-25	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	30
SUPPL	2	Null	6

CDER Filings

IMMUNOCORE LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761228
            [companyName] => IMMUNOCORE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KIMMTRAK","activeIngredients":"TEBENTAFUSP-TEBN","strength":"100MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761228s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761228s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761228Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-25
        )

)