FDA.reportPublic FDA data

Application 021629

Type
BLA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001APIDRAINSULIN GLULISINE RECOMBINANTINJECTABLE;INTRAVENOUS, SUBCUTANEOUS1000 UNITS/10ML (100 UNITS/ML)NoNo
002APIDRAINSULIN GLULISINE RECOMBINANTINJECTABLE;INTRAVENOUS, SUBCUTANEOUS300 UNITS/3ML (100 UNITS/ML)NoNo
003APIDRA SOLOSTARINSULIN GLULISINE RECOMBINANTINJECTABLE;SUBCUTANEOUS300 UNITS/3MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCNDACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCNDACurrent
0088-2500Apidrainsulin glulisineSanofi-Aventis U.S. LLCNDACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCNDACurrent
0088-2502Apidra SoloStarinsulin glulisinesanofi-aventis U.S. LLCNDACurrent
0088-2502Apidra SoloStarinsulin glulisineSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72778SUPPL2022-12-05
72758SUPPL2022-12-01
62457APPL2020-04-06
60966SUPPL2020-03-23
60965SUPPL2020-03-23
60911SUPPL2020-03-23
60910SUPPL2020-03-23
56973SUPPL2020-03-23
56972SUPPL2020-03-23
53298ORIG2020-03-23
53297ORIG2020-03-23
53296ORIG2020-03-23
42240SUPPL2020-03-23
42239ORIG2020-03-23
37356SUPPL2020-03-23
37355SUPPL2020-03-23
37354SUPPL2020-03-23
37353SUPPL2020-03-23
37352ORIG2020-03-23
28266SUPPL2020-03-23
28265SUPPL2020-03-23
28264SUPPL2020-03-23
15890SUPPL2020-03-23
15889SUPPL2020-03-23
15888SUPPL2020-03-23
15887SUPPL2020-03-23
5880SUPPL2020-03-23
5879SUPPL2020-03-23
5878SUPPL2020-03-23
5877ORIG2020-03-23
63526SUPPL1900-01-01
63525SUPPL1900-01-01
63524SUPPL1900-01-01