FDA.reportPublic FDA data

Application 020032

Type
BLA
Sponsor
ABBVIE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020032Survantaberactant351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SURVANTABERACTANTSUSPENSION;INTRATRACHEAL25MG/MLNoNo

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
SurvantaBERACTANTAbbVie Inc.7ef9e3a5-fc39-4ae1-0dad-6b47a16846352020-10-15Warnings, Adverse reactionsExact identifier
application number: BLA020032
ndc (product): 0074-1040

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.NDACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent
0074-1040SurvantaBeractantAbbVie Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71730SUPPL2022-08-05
71700SUPPL2022-08-03
65105SUPPL2020-10-30
65043SUPPL2020-10-27
62237APPL2020-03-23
61332SUPPL2020-03-23
61324SUPPL2020-03-23
21059SUPPL2020-03-23
21058SUPPL2020-03-23
1927SUPPL2020-03-23