Application 761136

Type
BLA
Sponsor
CELGENE CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REBLOZYLLUSPATERCEPT-AAMTPOWDER;SUBCUTANEOUS25MG/VIALNoNo
002REBLOZYLLUSPATERCEPT-AAMTPOWDER;SUBCUTANEOUS75MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-711ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-711ReblozylLuspaterceptCelgeneBLACurrent
59572-711LuspaterceptLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgeneBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775ReblozylLuspaterceptCelgene CorporationBLACurrent
59572-775LuspaterceptLuspaterceptCelgeneBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85281SUPPL 2026-03-06
85214SUPPL 2026-03-03
78505SUPPL 2024-05-20
78492SUPPL 2024-05-17
75318SUPPL 2023-08-29
75314SUPPL 2023-08-29
71535SUPPL2022-07-11
71531SUPPL2022-07-11
64881ORIG2020-10-08
62444ORIG2020-04-06
62441ORIG2020-04-06
61346ORIG2019-12-19
60817ORIG2019-11-12
60799ORIG2019-11-08