Insulin Lispro Pen Injector

Brand(s)
Humalog
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-08-04)
Oldest Current Product
2008-01-16
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN LISPRO
FDAOB
INJECTION\INJECTION\INSULIN LISPRO RECOMBINANT\rdfq
SUBCUTANEOUS\SOLUTION\INSULIN LISPRO RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN LISPRO
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN LISPRO

product(s) by strength(s)

3 ml insulin lispro 100 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000028799HumalogNDAEli Lilly And Company2008-01-16INSULIN LISPROSUBCUTANEOUSINJECTION, SOLUTIONNDA020563c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685899HumalogNDAPhysicians Total Care, Inc.2008-05-12INSULIN LISPROSUBCUTANEOUSINJECTION, SOLUTION000028725NDA020563ce8354f4-bf07-4923-8755-47f3163662e4

3 ml insulin lispro 200 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000027712HumalogNDAEli Lilly And Company2015-05-26INSULIN LISPROSUBCUTANEOUSINJECTION, SOLUTIONNDA205747c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA020563HUMALOGELI LILLY AND CO1996-06-14p7291132, SUBSTANCENEW ROUTE [2015-10-12]NDA020563_001, NDA020563_002, NDA020563_003Insulin Lispro Injectable Solution
Insulin Lispro Cartridge
2NDA205747HUMALOG KWIKPENELI LILLY AND CO2015-05-26p7291132, SUBSTANCE
p6034054, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS./ TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF., SUBSTANCE
p6551992, TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS./ TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF., SUBSTANCE
NDA205747_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020563_001RXINSULIN LISPRO RECOMBINANT (100 UNITS/ML)INJECTIONTrue1996-06-14HUMALOG
2NDA020563_002discontinuedINSULIN LISPRO RECOMBINANT (100 UNITS/ML)INJECTIONFalse1998-08-06HUMALOG
3NDA020563_003RXINSULIN LISPRO RECOMBINANT (100 UNITS/ML)INJECTIONTrue2007-09-06HUMALOG
4NDA205747_001RXINSULIN LISPRO RECOMBINANT (200 UNITS/ML)SUBCUTANEOUSSOLUTIONTrue2015-05-26HUMALOG KWIKPEN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6034054 (view patent)2018-06-11NDA205747
2p6551992 (view patent)2018-06-11NDA205747
3p7291132 (view patent)2024-08-09NDA020563, NDA205747, NDA018781, NDA019717, NDA021017, NDA021018insulin, isophane / Regular Insulin, Human Injectable Suspension
insulin, isophane Injectable Suspension
Insulin Lispro / Insulin, Protamine Lispro, Human Injectable Suspension
Insulin Lispro Injectable Solution
Insulin Lispro Cartridge
Insulin Lispro / Insulin, Protamine Lispro, Human Pen Injector

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f (view SPL)These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG.HUMALOG (insulin lispro injection), for subcutaneous or intravenous useInitial U.S. Approval: 1996prescriptionHuman PrescriptionEli Lilly And Company2015-08-0448000027712, 000028799, 000027510, 000027516Insulin Lispro Injectable Solution
Insulin Lispro Cartridge
2ce8354f4-bf07-4923-8755-47f3163662e4 (view SPL)These highlights do not include all the information needed to use HUMALOG safely and effectively. See full prescribing information for HUMALOG.Humalog (insulin lispro injection, USP [rDNA origin]) for injectionInitial U.S. Approval: 1996prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-05-223548685899, 548685108, 548685836Insulin Lispro Injectable Solution
Insulin Lispro Cartridge

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