FDA.reportPublic FDA data

Application 761169

Type
BLA
Sponsor
REGENERON PHARMACEUTICALS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761169Inmazebatoltivimab, maftivimab, and odesivimab-ebgn351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INMAZEBATOLTIVIMAB; ODESIVIMAB; MAFTIVIMABSOLUTION; INJECTION16.7MG/1MLNoNo

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
InmazebATOLTIVIMAB, MAFTIVIMAB, AND ODESIVIMAB-EBGNRegeneron Pharmaceuticals, Inc.0536b6fe-6fe5-4fd6-8cc6-1b481945c1fa2025-12-15Warnings, Adverse reactionsExact identifier
application number: BLA761169
ndc (product): 61755-019
ndc (product): 61755-018

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61755-018Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-018Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-018Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-018Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-018Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-019Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-019Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent
61755-019Inmazebatoltivimab, maftivimab, and odesivimab-ebgnRegeneron Pharmaceuticals, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80015SUPPL 2024-10-28
79986SUPPL 2024-10-25
73765SUPPL 2023-03-15
73764SUPPL 2023-03-15
71082SUPPL2022-05-16
71072SUPPL2022-05-16
65202ORIG2020-11-12
64925ORIG2020-10-15
64924ORIG2020-10-15