FDA.reportPublic FDA data

Application 125164

Type
BLA
Sponsor
HOFFMAN-LA ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIRCERAMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETASOLUTION; INJECTION0.6MG/KGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0401MirceraMethoxy polyethylene glycol-epoetin betaGenentech, Inc.BLACurrent
0004-0402MirceraMethoxy polyethylene glycol-epoetin betaGenentech, Inc.BLACurrent
0004-0403MirceraMethoxy polyethylene glycol-epoetin betaGenentech, Inc.BLACurrent
0004-0404MirceraMethoxy polyethylene glycol-epoetin betaGenentech, Inc.BLACurrent
0004-0406MirceraMethoxy polyethylene glycol-epoetin betaGenentech, Inc.BLACurrent
59353-400MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-400MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-400MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-401MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-401MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-401MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-402MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-402MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-402MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-403MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-403MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-403MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-404MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-404MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-404MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-405MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-405MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-405MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-406MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-406MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-406MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-407MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-407MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-407MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-408MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-408MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent
59353-408MirceraMethoxy polyethylene glycol-epoetin betaVifor (International) Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78647SUPPL 2024-06-05
78646SUPPL 2024-06-05
78636SUPPL 2024-06-05
78339SUPPL 2024-05-02
78324SUPPL 2024-05-01
73938SUPPL 2023-04-07
73931SUPPL 2023-04-07
71985SUPPL2022-08-31
71973SUPPL2022-08-31
54602SUPPL2018-06-14
54484SUPPL2018-06-08
54483SUPPL2018-06-08
31863SUPPL2016-05-02
31862SUPPL2016-05-02
9643SUPPL2016-05-02
39872SUPPL2016-04-29
18822SUPPL2016-04-29
18821SUPPL2016-04-29
18820SUPPL2015-08-25
9642SUPPL2015-08-24
39871SUPPL2014-10-03
31861SUPPL2014-10-03
43307ORIG2008-03-17
39870ORIG2007-11-15
63170SUPPL1900-01-01
63169SUPPL1900-01-01