FDA.reportPublic FDA data

Application 208780

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESBRIETPIRFENIDONETABLET;ORAL267MGYesNo
002ESBRIETPIRFENIDONETABLET;ORAL534MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003ESBRIETPIRFENIDONETABLET;ORAL801MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-122ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-123ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73646SUPPL 2023-03-01
73610SUPPL 2023-02-27
70164SUPPL2022-02-15
70154SUPPL2022-02-14
59561SUPPL2019-08-02
59538SUPPL2019-08-01
52676ORIG2018-02-21
46876ORIG2017-01-18
46800ORIG2017-01-11