FDA.reportPublic FDA data

Application 103172

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103172Activasealteplase351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTIVASEALTEPLASEVIAL; SINGLE-USE100MG/VIALNoNo
002ACTIVASEALTEPLASEVIAL; SINGLE-USE50MG/VIALNoNo
003CATHFLO ACTIVASEALTEPLASEVIAL2MG/VIALNoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cathflo ActivaseALTEPLASEGenentech, Inc.91ecdef2-95ff-42dd-a31c-c8a09cab3ad92026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172
ndc (product): 50242-041
ActivaseALTEPLASEGenentech, Inc.c669f77c-fa48-478b-a14b-80b20a0139c22026-01-20Warnings, Adverse reactionsExact identifier
application number: BLA103172
ndc (product): 50242-085
ndc (product): 50242-044

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-041Cathflo ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-041Cathflo ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-041Cathflo ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-041Cathflo ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-041Cathflo ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-044ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-044ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-044ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-044ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-085ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-085ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-085ActivaseAlteplaseGenentech, Inc.BLACurrent
50242-085ActivaseAlteplaseGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72003SUPPL2022-09-02
71996SUPPL2022-09-02
64886SUPPL2020-10-09
52976SUPPL2018-03-15
52969SUPPL2018-03-15
52804SUPPL2018-03-02
52801SUPPL2018-03-02
48913SUPPL2017-07-06
48910SUPPL2017-07-05
48903SUPPL2017-07-05
48888SUPPL2017-07-03
43263SUPPL2015-08-25
18562SUPPL2015-03-02
9373SUPPL2015-02-17
18561SUPPL2005-07-27
39633SUPPL2004-03-12
31563SUPPL2004-03-12
39634SUPPL2004-03-10
9372SUPPL2004-03-10