FDA.reportPublic FDA data

Application 103964

Type
BLA
Sponsor
HOFFMAN-LA ROCHE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103964Pegasyspeginterferon alfa-2a351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEGASYSPEGINTERFERON ALFA-2AVIAL; SUBCUTANEOUS180UG/VIALNoNo
002PEGASYSPEGINTERFERON ALFA-2ASYRINGE180U/5MLNoNo

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
PegasysPEGINTERFERON ALFA-2Apharmaand GmbHd9290e5b-6d40-2318-e053-2995a90a99162026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103964
ndc (product): 82154-0451
ndc (product): 82154-0449

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0350Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0357Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0365Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
0004-0365Pegasyspeginterferon alfa-2aGenentech, Inc.BLACurrent
82154-0449Pegasyspeginterferon alfa-2azr pharma& GmbHBLACurrent
82154-0451Pegasyspeginterferon alfa-2azr pharma& GmbHBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76773SUPPL 2023-12-12
76772SUPPL 2023-12-12
76771SUPPL 2023-12-12
66881SUPPL2021-03-25
66871SUPPL2021-03-25
64933SUPPL2020-10-16
64928SUPPL2020-10-16
50090SUPPL2017-10-18
50067SUPPL2017-10-17
50066SUPPL2017-10-17
39771SUPPL2015-03-19
31754SUPPL2015-03-19
39770SUPPL2014-09-09
31753SUPPL2014-09-08
31752SUPPL2013-07-03
18718SUPPL2013-07-03
39769SUPPL2013-05-21
31751SUPPL2013-05-21
31750SUPPL2011-10-05
39767SUPPL2011-10-04
9527SUPPL2011-08-26
39768SUPPL2011-08-24
39766SUPPL2011-08-11
9526SUPPL2011-08-11
18717SUPPL2011-05-31
18716SUPPL2011-03-04
31749SUPPL2011-03-02
9524SUPPL2010-06-29
9525SUPPL2010-03-31
9523SUPPL2009-05-08
9522SUPPL2009-05-08
39765SUPPL2009-05-07
39764SUPPL2009-05-07
18715SUPPL2009-01-16
18714SUPPL2009-01-16
9521SUPPL2008-11-07
31748SUPPL2008-10-02
18713SUPPL2007-07-05
9520SUPPL2007-07-05
39762SUPPL2005-05-20
31747SUPPL2005-05-20
31745SUPPL2005-05-20
9519SUPPL2005-05-20
31746SUPPL2005-03-03
39763SUPPL2005-02-25
31744SUPPL2005-01-26
18712SUPPL2005-01-26
39761ORIG2004-03-25
31743ORIG2004-03-25
22766ORIG2004-03-25
18711SUPPL2004-03-25
9518SUPPL2004-03-25
51545ORIG1900-01-01
51544ORIG1900-01-01
51543ORIG1900-01-01