FDA.reportPublic FDA data

Application 761089

Type
BLA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AJOVYFREMANEZUMAB-VFRMINJECTABLE;INJECTION150MG/MLNoNo

NDC Listings For This Application#

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