FDA.reportPublic FDA data

Application 210563

Type
NDA
Sponsor
PHARMACYCLICS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMBRUVICAIBRUTINIBTABLET;ORAL140MGYesNo
002IMBRUVICAIBRUTINIBTABLET;ORAL280MGYesNo
003IMBRUVICAIBRUTINIBTABLET;ORAL420MGYesNo
004IMBRUVICAIBRUTINIBTABLET;ORAL560MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-014ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-280ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-420ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent
57962-560ImbruvicaIbrutinibPharmacyclics LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83994SUPPL 2025-10-31
83881SUPPL 2025-10-23
80731SUPPL 2024-12-26
80727SUPPL 2024-12-26
78463SUPPL 2024-05-14
74334SUPPL 2023-05-22
74321SUPPL 2023-05-19
71967SUPPL2022-08-30
71893SUPPL2022-08-25
71071SUPPL2022-05-16
71070SUPPL2022-05-16
65749SUPPL2020-12-28
65722SUPPL2020-12-28
65688SUPPL2020-12-22
65678SUPPL2020-12-22
64259SUPPL2020-08-11
64243SUPPL2020-08-10
62627SUPPL2020-04-22
62623SUPPL2020-04-21
61037SUPPL2019-11-22
61027SUPPL2019-11-22
59631SUPPL2019-08-08
59348SUPPL2019-07-16
57573SUPPL2019-02-13
57373SUPPL2019-01-29
56108ORIG2018-10-26
56107ORIG2018-10-26
55349SUPPL2018-08-28
55345SUPPL2018-08-28
54222ORIG2018-05-17
52698ORIG2018-02-23
52679ORIG2018-02-21