NDA 208780

GENENTECH INC

FDA Drug Application

Application #208780

Documents

• Label: 2017-01-11
• Letter: 2017-01-18
• Review: 2018-02-21
• Letter: 2019-08-01
• Label: 2019-08-02
• Label: 2022-02-14
• Letter: 2022-02-15

Application Sponsors

NDA 208780

GENENTECH INC

Marketing Status

• Prescription: 001
• Discontinued: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	267MG	1	ESBRIET	PIRFENIDONE
002	TABLET;ORAL	534MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	ESBRIET	PIRFENIDONE
003	TABLET;ORAL	801MG	1	ESBRIET	PIRFENIDONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-01-11	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-07-31	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	7
SUPPL	5	Null	15

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

GENENTECH INC

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(
    [0] => Array
        (
            [ApplNo] => 208780
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESBRIET","activeIngredients":"PIRFENIDONE","strength":"267MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ESBRIET","activeIngredients":"PIRFENIDONE","strength":"534MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ESBRIET","activeIngredients":"PIRFENIDONE","strength":"801MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2019","submission":"SUPPL-2","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":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208780s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/11\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208780s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208780Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208780Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/31\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022535s012,208780s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"}]
            [actionDate] => 2019-07-31
        )

)