NDA 022535

GENENTECH INC

FDA Drug Application

Application #022535

Documents

• Letter: 2014-10-22
• Label: 2014-10-16
• Label: 2015-10-07
• Review: 2014-12-05
• Summary Review: 2014-12-05
• Label: 2017-01-11
• Letter: 2017-01-18
• Letter: 2019-08-01
• Label: 2019-08-02
• Label: 2022-02-14
• Letter: 2022-02-15

Application Sponsors

NDA 022535

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

267MG

1

ESBRIET

PIRFENIDONE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-10-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2016-06-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2017-01-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	2017-01-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-07-31	STANDARD
LABELING; Labeling	SUPPL	15	AP	2022-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	2	Null	0
SUPPL	5	Null	7
SUPPL	12	Orphan	5
SUPPL	15	Null	6

TE Codes

001

Prescription

AB

CDER Filings

GENENTECH INC

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(
    [0] => Array
        (
            [ApplNo] => 22535
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESBRIET","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022535s012,208780s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022535s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022535s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/15\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022535s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ESBRIET","submission":"PIRFENIDONE","actionType":"267MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-31
        )

)