BLA 761073

AMGEN INC

FDA Drug Application

Application #761073

Documents

• Label: 2019-06-13
• Letter: 2019-06-13
• Review: 2019-07-18
• Letter: 2020-10-21
• Label: 2020-10-21

Application Sponsors

BLA 761073

AMGEN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	420MG	0	KANJINTI	TRASTUZUMAB-ANNS
002	VIAL;SINGLE-DOSE	150MG	0	KANJINTI	TRASTUZUMAB-ANNS

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-13

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761073
            [companyName] => AMGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KANJINTI","activeIngredients":"TRASTUZUMAB-ANNS","strength":"420MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/13\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761073Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761073Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761073Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761073Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-06-13
        )

)