FDA.reportPublic FDA data

Application 021629

Type
BLA
Sponsor
SANOFI AVENTIS US

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021629Apidrainsulin glulisine351(a)Rx2026-09-01

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ApidraINSULIN GLULISINEsanofi-aventis U.S. LLCe7af6a7a-8046-4fb4-9979-4ec4230b23aa2025-11-25Warnings, Adverse reactionsExact identifier
application number: BLA021629
ndc (product): 0088-2500
ndc (product): 0088-2502

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

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. LLCNDACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCNDACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
0088-2500Apidrainsulin glulisinesanofi-aventis U.S. LLCBLACurrent
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. LLCNDACurrent
0088-2502Apidra SoloStarinsulin 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. 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