FDA.reportPublic FDA data

Application 022535

Type
NDA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESBRIETPIRFENIDONECAPSULE;ORAL267MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
50242-121ESBRIETPIRFENIDONEGenentech, Inc.NDACurrent
64116-121EsbrietpirfenidoneInterMune, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73647SUPPL 2023-03-01
73611SUPPL 2023-02-27
70163SUPPL2022-02-15
70153SUPPL2022-02-14
59560SUPPL2019-08-02
59537SUPPL2019-08-01
46875SUPPL2017-01-18
46801SUPPL2017-01-11
38824SUPPL2015-10-07
44773ORIG2014-12-05
42554ORIG2014-12-05
7513ORIG2014-10-22
17690ORIG2014-10-16