FDA.reportPublic FDA data

Application 761055

Type
BLA
Sponsor
REGENERON PHARMACEUTICALS

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761055Dupixentdupilumab351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUPIXENTDUPILUMABINJECTABLE; 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
DupixentDUPILUMABSanofi-Aventis U.S. LLC595f437d-2729-40bb-9c62-c8ece1f827802026-04-22Warnings, Adverse reactionsExact identifier
application number: BLA761055
ndc (product): 0024-5919

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5919DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85740SUPPL 2026-04-24
85736SUPPL 2026-04-24
85728SUPPL 2026-04-21
85715SUPPL 2026-04-20
85151SUPPL 2026-02-24
85139SUPPL 2026-02-24
82624SUPPL 2025-06-20
82615SUPPL 2025-06-20
82026SUPPL 2025-04-28
82015SUPPL 2025-04-28
81963SUPPL 2025-04-24
81962SUPPL 2025-04-24
79776SUPPL 2024-09-30
79762SUPPL 2024-09-30
79621SUPPL 2024-09-16
79596SUPPL 2024-09-16
78138SUPPL 2024-04-15
78134SUPPL 2024-04-15
77320SUPPL 2024-01-26
77306SUPPL 2024-01-26
77221SUPPL 2024-01-16
77214SUPPL 2024-01-16
75657SUPPL 2023-10-03
75652SUPPL 2023-10-03
74776SUPPL 2023-07-19
74767SUPPL 2023-07-17
72424SUPPL2022-10-19
72184SUPPL2022-09-29
72178SUPPL2022-09-29
71649SUPPL2022-07-28
71257SUPPL2022-06-08
71251SUPPL2022-06-08
71131SUPPL2022-05-23
71128SUPPL2022-05-23
70726SUPPL2022-04-07
69775SUPPL2021-12-27
69774SUPPL2021-12-27
69773SUPPL2021-12-27
69770SUPPL2021-12-27
69769SUPPL2021-12-27
69768SUPPL2021-12-27
69110SUPPL2021-10-25
69076SUPPL2021-10-22
68881SUPPL2021-10-05
68848SUPPL2021-10-01
67824SUPPL2021-06-15
67819SUPPL2021-06-15
64014SUPPL2020-07-22
63671SUPPL2020-06-23
63670SUPPL2020-06-23
63635SUPPL2020-06-19
63634SUPPL2020-06-19
63331SUPPL2020-05-29
63308SUPPL2020-05-27
61965SUPPL2020-02-26
59189SUPPL2019-06-27
59185SUPPL2019-06-27
57998SUPPL2019-03-14
57951SUPPL2019-03-11
56083SUPPL2018-10-23
56046SUPPL2018-10-22
53656SUPPL2018-04-12
53650SUPPL2018-04-11
51032SUPPL2018-01-11
51028SUPPL2018-01-11
48179ORIG2017-05-01
47774ORIG2017-03-30
47773ORIG2017-03-30