FDA.reportPublic FDA data

Application 208051

Type
NDA
Sponsor
PUMA BIOTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NERLYNXNERATINIB MALEATETABLET;ORALEQ 40MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent
70437-240NerlynxneratinibPuma Biotechnology, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67990SUPPL2021-06-30
69276SUPPL2021-06-29
64140SUPPL2020-07-30
64139SUPPL2020-07-30
61968SUPPL2020-02-26
61967SUPPL2020-02-26
61964SUPPL2020-02-26
61963SUPPL2020-02-26
60200SUPPL2019-10-02
60198SUPPL2019-10-02
58355SUPPL2019-04-19
54830SUPPL2018-07-06
54810SUPPL2018-07-06
54771SUPPL2018-07-05
49467ORIG2017-08-21
49007ORIG2017-07-18
48998ORIG2017-07-17