Application 022561

Type
NDA
Sponsor
EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAVENCLADCLADRIBINETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-4000MavencladCladribineEMD Serono, Inc.NDACurrent
44087-4000MavencladCladribineEMD Serono, Inc.NDACurrent
44087-4000MavencladCladribineEMD Serono, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85998SUPPL 2026-05-21
85967SUPPL 2026-05-19
85952SUPPL 2026-05-18
78472SUPPL 2024-05-15
78471SUPPL 2024-05-15
78450SUPPL 2024-05-13
77501SUPPL 2024-02-15
77500SUPPL 2024-02-15
76751SUPPL 2023-12-07
76748SUPPL 2023-12-07
72112SUPPL2022-09-20
72111SUPPL2022-09-20
72110SUPPL2022-09-20
59603ORIG2019-08-06
58163ORIG2019-04-05
58203ORIG2019-04-04
58164ORIG2019-04-01