FDA.reportPublic FDA data

Application 208471

Type
BLA
Sponsor
SANOFI-AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADLYXINLIXISENATIDESOLUTION;SUBCUTANEOUS0.15MG/3ML (0.05MG/ML)NoNo
002ADLYXINLIXISENATIDESOLUTION;SUBCUTANEOUS0.3MG/3ML (0.1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5745ADLYXINLixisenatidesanofi-aventis U.S. LLCBLACurrent
0024-5745ADLYXINLixisenatideSanofi-Aventis U.S. LLCBLACurrent
0024-5745ADLYXINLixisenatidesanofi-aventis U.S. LLCBLACurrent
0024-5745ADLYXINLixisenatideSanofi-Aventis U.S. LLCNDACurrent
0024-5747ADLYXINLixisenatidesanofi-aventis U.S. LLCBLACurrent
0024-5747ADLYXINLixisenatideSanofi-Aventis U.S. LLCBLACurrent
0024-5747ADLYXINLixisenatidesanofi-aventis U.S. LLCBLACurrent
0024-5747ADLYXINLixisenatideSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85387SUPPL 2026-03-18
85374SUPPL 2026-03-16
85388SUPPL 2026-03-12
82390SUPPL 2025-06-02
82346SUPPL 2025-05-29
80123SUPPL 2024-11-05
80113SUPPL 2024-11-04
75623SUPPL 2023-09-29
75612SUPPL 2023-09-29
71311SUPPL2022-06-15
71308SUPPL2022-06-15
71275SUPPL2022-06-13
68271SUPPL2021-08-03
68270SUPPL2021-08-03
68246SUPPL2021-08-02
62459APPL2020-04-07
47164ORIG2020-03-23
45985ORIG2020-03-23
40635ORIG2020-03-23
32910ORIG2020-03-23