NDA 214665

AMGEN INC

FDA Drug Application

Application #214665

Documents

• Label: 2021-05-28
• Letter: 2021-06-01
• Review: 2021-06-24
• Letter: 2022-11-22
• Label: 2022-11-23
• Label: 2023-01-23
• Letter: 2023-01-23

Application Sponsors

NDA 214665

AMGEN INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

120MG

0

LUMAKRAS

SOTORASIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-05-28	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-11-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2023-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	30
SUPPL	2	Null	6
SUPPL	3	Null	6

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214665
            [companyName] => AMGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMAKRAS","activeIngredients":"SOTORASIB","strength":"120MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214665s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/28\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214665s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214665Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-28
        )

)