FDA.reportPublic FDA data

Application 209196

Type
BLA
Sponsor
SANOFI-AVENTIS US

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
209196Admeloginsulin lispro351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ADMELOGINSULIN LISPROSOLUTION;INTRAVENOUS, SUBCUTANEOUS1000 UNITS/10ML (100 UNITS/ML)NoNo
002ADMELOG SOLOSTARINSULIN LISPROSOLUTION;INTRAVENOUS, SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
003ADMELOGINSULIN LISPROSOLUTION;INTRAVENOUS, SUBCUTANEOUS300 UNITS/3ML (100 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADMELOGINSULIN LISPROREMEDYREPACK INC.12ec9e3f-e2ac-43a1-b334-8b6538cf2bb02025-10-01Warnings, Adverse reactionsExact identifier
application number: BLA209196
ADMELOGINSULIN LISPROSanofi-Aventis U.S. LLC0691def8-4a7b-4de3-866f-a280989f47f12025-06-04Warnings, Adverse reactionsExact identifier
application number: BLA209196
ndc (product): 0024-5925
ndc (product): 0024-5924
ndc (product): 0024-5926

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5924ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5925ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCNDACurrent
0024-5926ADMELOGinsulin lisproSanofi-Aventis U.S. LLCBLACurrent
70518-2399ADMELOGinsulin lisproREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75345SUPPL 2023-09-01
75336SUPPL 2023-09-01
66378APPL2020-03-23
60962SUPPL2020-03-23
60961SUPPL2020-03-23
60907SUPPL2020-03-23
60906SUPPL2020-03-23
56301SUPPL2020-03-23
56245SUPPL2020-03-23
54229ORIG2020-03-23
50682ORIG2020-03-23
50675ORIG2020-03-23