FDA.reportPublic FDA data

Application 761089

Type
BLA
Sponsor
TEVA PHARMS USA

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761089Ajovyfremanezumab-vfrm351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AJOVYFREMANEZUMAB-VFRMINJECTABLE;INJECTION150MG/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
AJOVYFREMANEZUMAB-VFRMTeva Pharmaceuticals USA, Inc.98e344ea-5916-4947-b6f2-4a76ccc04b6b2026-06-05Warnings, Adverse reactionsExact identifier
application number: BLA761089
ndc (product): 51759-202
ndc (product): 51759-204

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-202AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent
51759-204AJOVYfremanezumab-vfrmTeva Pharmaceuticals USA, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83054SUPPL 2025-08-06
83053SUPPL 2025-08-05
81721SUPPL 2025-03-25
81695SUPPL 2025-03-24
68806SUPPL2021-09-29
68795SUPPL2021-09-28
61714SUPPL2020-01-28
61707SUPPL2020-01-28
55955ORIG2018-10-16
55509ORIG2018-09-18
55492ORIG2018-09-14