GENENTECH FDA Approval BLA 125472

Application #125472

Documents

Letter	2013-10-24
Letter	2015-08-21
Label	2013-10-25
Review	2014-07-17
Summary Review	2014-07-17
Label	2016-09-27
Letter	2016-09-26
Label	2017-03-31
Letter	2017-04-03
Letter	2017-05-24
Label	2017-05-24
Label	2018-03-22
Letter	2018-03-28
Label	2018-05-14
Letter	2018-05-16
Label	2018-05-21
Letter	2018-05-21
Label	2018-09-13
Letter	2018-09-14
Label	2018-11-20
Letter	2018-11-20
Letter	2018-12-21
Label	2018-12-21
Label	2019-04-12
Letter	2019-04-15
Letter	2019-06-12
Label	2019-06-12
Medication Guide	2019-06-12
Review	2019-11-20
Label	2020-05-29
Medication Guide	2020-05-29
Letter	2020-06-01
Letter	2021-03-08
Label	2021-03-09
Medication Guide	2021-03-09
Letter	2021-10-25
Letter	2022-03-01
Label	2022-03-01
Medication Guide	2022-03-01
Review	2022-07-12
Label	2022-12-22
Medication Guide	2022-12-22
Letter	2022-12-22

Application Sponsors

BLA 125472

GENENTECH

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

162MG/0.9ML

ACTEMRA

TOCILIZUMAB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-10-21	STANDARD
REMS; REMS	SUPPL	14	AP	2015-08-18	N/A
EFFICACY; Efficacy	SUPPL	18	AP	2016-09-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2017-03-30	STANDARD
EFFICACY; Efficacy	SUPPL	24	AP	2017-05-22	PRIORITY
EFFICACY; Efficacy	SUPPL	28	AP	2018-05-11	PRIORITY
EFFICACY; Efficacy	SUPPL	29	AP	2018-11-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2018-03-22	STANDARD
EFFICACY; Efficacy	SUPPL	31	AP	2018-09-12	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2018-05-17	STANDARD
LABELING; Labeling	SUPPL	37	AP	2019-04-11	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	40	AP	2019-06-11	901 REQUIRED
LABELING; Labeling	SUPPL	42	AP	2020-05-28	STANDARD
EFFICACY; Efficacy	SUPPL	44	AP	2021-03-04	PRIORITY
LABELING; Labeling	SUPPL	45	AP	2021-10-22	STANDARD
LABELING; Labeling	SUPPL	46	AP	2022-02-28	STANDARD
LABELING; Labeling	SUPPL	49	AP	2022-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	14	Null	7
SUPPL	18	Null	15
SUPPL	23	Null	15
SUPPL	24	Null	15
SUPPL	28	Null	6
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	15
SUPPL	32	Null	6
SUPPL	37	Null	15
SUPPL	38	Null	6
SUPPL	40	Null	15
SUPPL	42	Null	6
SUPPL	44	Null	15
SUPPL	45	Null	15
SUPPL	46	Null	6
SUPPL	49	Null	6

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125472
            [companyName] => GENENTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125276s129,125472s042lbl.pdf#page=46"]
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            [supplements] => [{"actionDate":"05\/28\/2020","submission":"SUPPL-42","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125276s129,125472s042lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125472Orig1s042,125276Orig1s129ltr.pdf\"}]","notes":">"},{"actionDate":"06\/11\/2019","submission":"SUPPL-40","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125276s127,125472s040lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/20\/2018","submission":"SUPPL-38","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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this site."}]
            [actionDate] => 2020-05-28
        )

)

BLA 125472

GENENTECH

FDA Drug Application

Application #125472

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

GENENTECH