FDA.reportPublic FDA data

Application 208447

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEJULANIRAPARIB TOSYLATECAPSULE;ORALEQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibTESARO, Inc.NDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibTESARO, Inc.NDACurrent
69656-103ZEJULAniraparibGlaxoSmithKline LLCNDACurrent
69656-103ZEJULAniraparibTESARO, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74102SUPPL 2023-04-27
74084SUPPL 2023-04-27
72874SUPPL2022-12-13
72854SUPPL2022-12-09
72083SUPPL2022-09-15
72082SUPPL2022-09-15
68214SUPPL2021-07-28
68213SUPPL2021-07-28
68212SUPPL2021-07-28
68211SUPPL2021-07-28
66488SUPPL2021-03-04
66487SUPPL2021-03-04
66486SUPPL2021-03-04
66485SUPPL2021-03-04
63384SUPPL2020-06-02
62747SUPPL2020-04-30
62746SUPPL2020-04-30
62742SUPPL2020-04-29
62741SUPPL2020-04-29
61982SUPPL2020-02-27
61976SUPPL2020-02-27
60648SUPPL2019-10-24
60639SUPPL2019-10-23
48076ORIG2017-04-21
47760ORIG2017-03-29
47716ORIG2017-03-27