FDA.reportPublic FDA data

Application 125164

Type
BLA
Sponsor
HOFFMAN-LA ROCHE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125164Mirceramethoxy polyethylene glycol-epoetin beta351(a)Rx2026-09-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirceraMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETAVifor (International) Inc.22c56f2a-f73c-60e7-e054-00144ff88e882026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125164
ndc (product): 59353-408
ndc (product): 59353-400
ndc (product): 59353-406
ndc (product): 59353-404
ndc (product): 59353-405
ndc (product): 59353-403
ndc (product): 59353-401
ndc (product): 59353-407
ndc (product): 59353-402

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

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