Insulin Glargine Pen Injector

Brand(s)
Lantus, Toujeo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi-Aventis U.S. Llc (2015-10-15)
Oldest Current Product
2007-04-04
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN GLARGINE
FDAOB
INJECTION\INJECTION\INSULIN GLARGINE RECOMBINANT\rdfq
SUBCUTANEOUS\SOLUTION\INSULIN GLARGINE RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN GLARGINE

product(s) by strength(s)

3 ml insulin glargine 100 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000882219LantusNDASanofi-Aventis U.S. Llc2009-09-23INSULIN GLARGINESUBCUTANEOUSINJECTION, SOLUTIONNDA021081d5e07a0c-7e14-4756-9152-9fea485d654a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685765LantusNDAPhysicians Total Care, Inc.2007-04-04INSULIN GLARGINESUBCUTANEOUSINJECTION, SOLUTION000882220NDA021081b861fdd9-e134-436e-8c0c-a60dd0006dd3
2548686231LantusNDAPhysicians Total Care, Inc.2011-02-07INSULIN GLARGINESUBCUTANEOUSINJECTION, SOLUTION000882219NDA021081b861fdd9-e134-436e-8c0c-a60dd0006dd3

1.5 ml insulin glargine 300 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245869ToujeoNDASanofi-Aventis U.S. Llc2015-02-25INSULIN GLARGINESUBCUTANEOUSINJECTION, SOLUTIONNDA206538c9561d96-124d-48ca-982f-0aa1575bff36

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA021081LANTUSSANOFI AVENTIS US LLC2000-04-20p9011391, SUBSTANCE
p8603044, SUBSTANCE
p5656722, TREATMENT OF DIABETES MELLITUS, SUBSTANCE
p8992486, SUBSTANCE
p7918833, SUBSTANCE
p8512297, SUBSTANCE
p7713930, SUBSTANCE
p8679069, SUBSTANCE
p8556864, SUBSTANCE
p7476652, SUBSTANCE
NDA021081_001, NDA021081_002Insulin Glargine Injectable Solution
2NDA206538TOUJEO SOLOSTARSANOFI US SERVICES INC2015-02-25p8603044, SUBSTANCE
p8992486, SUBSTANCE
p7918833, SUBSTANCE
p8556864, SUBSTANCE
p9011391, SUBSTANCE
p8679069, SUBSTANCE
p8512297, SUBSTANCE
NEW PRODUCT [2018-02-25]NDA206538_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021081_001RXINSULIN GLARGINE RECOMBINANT (100 UNITS/ML)INJECTIONTrue2000-04-20LANTUS
2NDA021081_002RXINSULIN GLARGINE RECOMBINANT (300 UNITS/3ML)INJECTIONTrue2007-04-27LANTUS
3NDA206538_001RXINSULIN GLARGINE RECOMBINANT (300 UNITS/ML)SUBCUTANEOUSSOLUTIONTrue2015-02-25TOUJEO SOLOSTAR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5656722 (view patent)2014-08-12NDA021081Insulin Glargine Injectable Solution
2p7476652 (view patent)2023-07-23NDA021081Insulin Glargine Injectable Solution
3p7713930 (view patent)2023-06-13NDA021081Insulin Glargine Injectable Solution
4p7918833 (view patent)2027-09-23NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
5p8512297 (view patent)2024-09-15NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
6p8556864 (view patent)2024-03-03NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
7p8603044 (view patent)2024-03-02NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
8p8679069 (view patent)2025-04-12NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
9p8992486 (view patent)2024-06-05NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution
10p9011391 (view patent)2024-03-26NDA021081, NDA206538, NDA021629Insulin, Glulisine, Human Injectable Solution
Insulin, Glulisine, Human Pen Injector
Insulin Glargine Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1b861fdd9-e134-436e-8c0c-a60dd0006dd3 (view SPL)These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine [rDNA origin] injection) solution for subcutaneous injection Initial U.S. Approval: 2000prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-052548685765, 548686231, 548684626Insulin Glargine Injectable Solution
2c9561d96-124d-48ca-982f-0aa1575bff36 (view SPL)These highlights do not include all the information needed to use TOUJEO safely and effectively. See full prescribing information for TOUJEO. TOUJEO (insulin glargine injection) U-300, for subcutaneous useInitial U.S. Approval: 2015prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-10-157000245869
3d5e07a0c-7e14-4756-9152-9fea485d654a (view SPL)These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS (insulin glargine injection) solution for subcutaneous injectionInitial U.S. Approval: 2000prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-08-0522000882219, 000882220Insulin Glargine Injectable Solution

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