FDA.reportPublic FDA data

Application 213217

Type
NDA
Sponsor
BEIGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRUKINSAZANUBRUTINIBCAPSULE;ORAL80MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72579-011BRUKINSAzanubrutinibBEIGENE USA, INC.NDACurrent
72579-011BRUKINSAzanubrutinibBeiGene USA, Inc.NDACurrent
72579-011BRUKINSAzanubrutinibBEIGENE USA, INC.NDACurrent
72579-011BRUKINSAzanubrutinibBeiGene USA, Inc.NDACurrent
72579-011BRUKINSAzanubrutinibBeigene Usa, Inc.NDACurrent
72579-011BRUKINSAzanubrutinibBeigene Usa, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81097SUPPL 2025-02-06
80980SUPPL 2025-02-05
78632SUPPL 2024-07-02
78645SUPPL 2024-06-05
78576SUPPL 2024-05-29
78347SUPPL 2024-05-02
77761SUPPL 2024-03-08
77756SUPPL 2024-03-07
77110SUPPL 2023-12-22
77101SUPPL 2023-12-21
74052SUPPL 2023-04-24
74038SUPPL 2023-04-24
73258SUPPL2023-01-20
73254SUPPL2023-01-20
68626SUPPL2021-09-20
68621SUPPL2021-09-15
68512SUPPL2021-09-01
68510SUPPL2021-09-01
61083ORIG2019-11-27
60849ORIG2019-11-15
60841ORIG2019-11-14