FDA.reportPublic FDA data

Application 020521

Type
BLA
Sponsor
ONY

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
020521Infasurfcalfactant351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFASURF PRESERVATIVE FREECALFACTANTSUSPENSION;INTRATRACHEAL35MG/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
INFASURFCALFACTANTONY Biotech Inc.315c128a-272d-4c57-bfbe-1a8b3402af082026-03-31Warnings, Adverse reactionsExact identifier
application number: BLA020521
ndc (product): 61938-456

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61938-456INFASURFCALFACTANTONY Biotech Inc.BLACurrent
61938-456INFASURFCALFACTANTONY Biotech Inc.NDACurrent
61938-456INFASURFCALFACTANTOny, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79478SUPPL 2024-08-26
79468SUPPL 2024-08-26
62242APPL2020-03-23
34761SUPPL2020-03-23
34760ORIG2020-03-23
25104SUPPL2020-03-23
25103ORIG2020-03-23
20699ORIG2020-03-23
2658SUPPL2020-03-23