BLA 761145

JANSSEN BIOTECH

FDA Drug Application

Application #761145

Documents

• Label: 2020-05-01
• Letter: 2020-05-05
• Label: 2021-01-14
• Label: 2021-01-15
• Letter: 2021-02-01
• Letter: 2021-02-09
• Label: 2021-02-16
• Label: 2021-03-15
• Letter: 2021-03-16
• Review: 2021-05-26
• Label: 2021-07-12
• Letter: 2021-07-13
• Label: 2021-12-01
• Letter: 2021-12-01
• Letter: 2022-01-25
• Label: 2022-01-26
• Letter: 2022-11-03
• Label: 2022-11-04

Application Sponsors

BLA 761145

JANSSEN BIOTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

120MG;2000UNITS/ML

0

DARZALEX FASPRO

DARATUMUMAB;HYALURONIDASE-FIHJ

FDA Submissions

UNKNOWN;	ORIG	1	AP	2020-05-01	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2021-01-15	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2021-03-12	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2021-07-09	STANDARD
LABELING; Labeling	SUPPL	8	AP	2021-02-08	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2021-11-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-01-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2022-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	5	Null	7
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	12	Null	7
SUPPL	18	Null	6

CDER Filings

JANSSEN BIOTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761145
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"DARZALEX FASPRO","activeIngredients":"DARATUMUMAB;HYALURONIDASE-FIHJ","strength":"120MG;2000UNITS\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761145s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761145s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761145Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-01
        )

)