FDA.reportPublic FDA data

Application 761055

Type
BLA
Sponsor
REGENERON PHARMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUPIXENTDUPILUMABINJECTABLE; INJECTION150MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5911DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5914DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5915DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5916DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-aventis U.S. LLCBLACurrent
0024-5918DupixentDupilumabsanofi-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