BLA 761270

ASTRAZENECA AB

FDA Drug Application

Application #761270

Documents

• Medication Guide: 2022-11-13
• Label: 2022-11-13
• Letter: 2022-11-14

Application Sponsors

BLA 761270

ASTRAZENECA AB

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	25MG/1.25ML(20MG/ML)	0	IMJUDO	TREMELIMUMAB-ACTL
002	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	300MG/15ML(20MG/ML)	0	IMJUDO	TREMELIMUMAB-ACTL

FDA Submissions

TYPE 9- BLA; Type 9 - New indication submitted as distinct BLA, consolidated

ORIG

1

AP

2022-11-10

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761270
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761270s000lbl.pdf#page=32"]
            [products] => [{"drugName":"IMJUDO","activeIngredients":"TREMELIMUMAB-ACTL","strength":"25MG\/1.25ML(20MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMJUDO","activeIngredients":"TREMELIMUMAB-ACTL","strength":"300MG\/15ML(20MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/10\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761270s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/10\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761270s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761270Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-11-10
        )

)