FDA.reportPublic FDA data

Application 209936

Type
NDA
Sponsor
BAYER HEALTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALIQOPACOPANLISIB DIHYDROCHLORIDEPOWDER;INTRAVENOUS60MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent
50419-385ALIQOPAcopanlisibBayer HealthCare Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75375SUPPL 2023-09-08
75369SUPPL 2023-09-07
73915SUPPL 2023-03-31
73911SUPPL 2023-03-31
70258SUPPL2022-02-25
70241SUPPL2022-02-24
61885SUPPL2020-02-13
61878SUPPL2020-02-13
60706SUPPL2019-10-29
60698SUPPL2019-10-29
58937SUPPL2019-06-04
58872SUPPL2019-05-29
50061ORIG2017-10-16
49731ORIG2017-09-14
49730ORIG2017-09-14