NDA 213674

ASTELLAS

FDA Drug Application

Application #213674

Documents

• Label: 2020-08-05
• Review: 2021-01-25
• Label: 2021-05-25
• Letter: 2021-05-25
• Letter: 2022-01-18
• Label: 2022-01-19
• Letter: 2022-09-12
• Label: 2022-09-13

Application Sponsors

NDA 213674

ASTELLAS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, FILM COATED	40MG	2	XTANDI	ENZALUTAMIDE
002	TABLET, FILM COATED	80MG	2	XTANDI	ENZALUTAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2020-08-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-05-24	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-01-13	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2022-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	5	Null	7
SUPPL	6	Null	6

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213674
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"XTANDI","activeIngredients":"ENZALUTAMIDE","strength":"40MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"XTANDI","activeIngredients":"ENZALUTAMIDE","strength":"80MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/04\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213674s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213674s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-04
        )

)