FDA.reportPublic FDA data

Application 206538

Type
BLA
Sponsor
SANOFI US SERVICES

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
206538Toujeoinsulin glargine351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOUJEO SOLOSTARINSULIN GLARGINE RECOMBINANTSOLUTION;SUBCUTANEOUS450 UNITS/1.5ML (300 UNITS/ML)NoNo
002TOUJEO MAX SOLOSTARINSULIN GLARGINE RECOMBINANTSOLUTION;SUBCUTANEOUS900 UNITS/3ML (300 UNITS/ML)NoNo

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOUJEOINSULIN GLARGINESanofi-Aventis U.S. LLCc9561d96-124d-48ca-982f-0aa1575bff362025-05-30Warnings, Adverse reactionsExact identifier
application number: BLA206538
ndc (product): 0024-5871
ndc (product): 0024-5869
Insulin glargine U-300 MaxINSULIN GLARGINESanofi-Aventis U.S. LLC99ea856d-9562-443a-9422-1006a3cff2f42025-05-30Warnings, Adverse reactionsExact identifier
application number: BLA206538
TOUJEO MaxINSULIN GLARGINEA-S Medication Solutions620b9a3d-8d8c-4c0a-b5a2-f269d6cc9ab92023-07-12Warnings, Adverse reactionsExact identifier
application number: BLA206538
ndc (product): 50090-4177
TOUJEOINSULIN GLARGINEA-S Medication Solutions257ca17b-6ff7-4f2e-9037-4c185bac57682023-04-27Warnings, Adverse reactionsExact identifier
application number: BLA206538
ndc (product): 50090-2193

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
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5869TOUJEOinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCBLACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
0024-5871TOUJEO Maxinsulin glargineSanofi-Aventis U.S. LLCNDACurrent
50090-2193TOUJEOinsulin glargineA-S Medication SolutionsNDACurrent
50090-2193TOUJEOinsulin glargineA-S Medication SolutionsBLACurrent
50090-4177TOUJEO Maxinsulin glargineA-S Medication SolutionsNDACurrent
50090-4177TOUJEO Maxinsulin glargineA-S Medication SolutionsBLACurrent
50090-4177TOUJEO Maxinsulin glargineA-S Medication SolutionsBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79508SUPPL 2024-08-30
79507SUPPL 2024-08-30
71834SUPPL2022-08-17
71814SUPPL2022-08-17
64202SUPPL2020-08-05
62440APPL2020-04-05
61101SUPPL2020-03-23
61080SUPPL2020-03-23
60964SUPPL2020-03-23
60963SUPPL2020-03-23
60913SUPPL2020-03-23
60912SUPPL2020-03-23
56113SUPPL2020-03-23
56112SUPPL2020-03-23
53517SUPPL2020-03-23
53455SUPPL2020-03-23
49434SUPPL2020-03-23
43523ORIG2020-03-23
40555ORIG2020-03-23
24519ORIG2020-03-23
10577ORIG2020-03-23