FDA.reportPublic FDA data

Application 209196

Type
BLA
Sponsor
SANOFI-AVENTIS US

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

NDC Listings For This Application#

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