Insulin, Glulisine, Human Pen Injector

Brand(s)
Apidra
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-03-19)
Oldest Current Product
2009-02-24
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN, GLULISINE, HUMAN
FDAOB
IV (INFUSION), SUBCUTANEOUS\INJECTION\INSULIN GLULISINE RECOMBINANT\rdfq
SUBCUTANEOUS\INJECTION\INSULIN GLULISINE RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLULISINE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLULISINE

product(s) by strength(s)

3 ml insulin, glulisine, human 100 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000882502ApidraNDASanofi-Aventis U.S. Llc2009-02-24INSULIN GLULISINESUBCUTANEOUSINJECTION, SOLUTIONNDA021629e7af6a7a-8046-4fb4-9979-4ec4230b23aa

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1NDA021629APIDRASANOFI AVENTIS US LLC2004-04-16p8512297, SUBSTANCE
p7452860, SUBSTANCE
p8603044, SUBSTANCE
p6221633, METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS, SUBSTANCE
p7696162, METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS, SUBSTANCE
p7918833, SUBSTANCE
p8992486, SUBSTANCE
p9011391, SUBSTANCE
p8679069, SUBSTANCE
p6960561, METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS, SUBSTANCE
p8556864, SUBSTANCE
NDA021629_001, NDA021629_002, NDA021629_003Insulin, Glulisine, Human Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021629_001RXINSULIN GLULISINE RECOMBINANT (1000 UNITS/10ML)INJECTIONTrue2004-04-16APIDRA
2NDA021629_002RXINSULIN GLULISINE RECOMBINANT (300 UNITS/3ML)INJECTIONTrue2005-12-20APIDRA
3NDA021629_003RXINSULIN GLULISINE RECOMBINANT (300 UNITS/3ML)SUBCUTANEOUSINJECTIONFalse2009-02-24APIDRA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6221633 (view patent)2018-06-18NDA021629Insulin, Glulisine, Human Injectable Solution
2p6960561 (view patent)2023-01-25NDA021629Insulin, Glulisine, Human Injectable Solution
3p7452860 (view patent)2022-03-22NDA021629Insulin, Glulisine, Human Injectable Solution
4p7696162 (view patent)2022-03-22NDA021629Insulin, Glulisine, Human Injectable Solution
5p7918833 (view patent)2027-09-23NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
6p8512297 (view patent)2024-09-15NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
7p8556864 (view patent)2024-03-03NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
8p8603044 (view patent)2024-03-02NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
9p8679069 (view patent)2025-04-12NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
10p8992486 (view patent)2024-06-05NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution
11p9011391 (view patent)2024-03-26NDA021629, NDA021081, NDA206538Insulin, Glulisine, Human Injectable Solution
Insulin Glargine Pen Injector
Insulin Glargine Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1e7af6a7a-8046-4fb4-9979-4ec4230b23aa (view SPL)These highlights do not include all the information needed to use APIDRA safely and effectively. See full prescribing information for APIDRA. APIDRA (insulin glulisine [rDNA origin] injection) solution for injectionInitial U.S. Approval: 2004prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-03-1915000882502, 000882500Insulin, Glulisine, Human Injectable Solution

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII