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)Rx2026-06-01

Application Products#

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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-e053-2995a90a99162026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103964
ndc (product): 82154-0451
ndc (product): 82154-0449

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