Insulin Lispro Cartridge

Brand(s)
Humalog
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-08-04)
Oldest Current Product
1998-02-20
License(s)
NDA
RxNORM
CARTRIDGE\INSULIN LISPRO
FDAOB
INJECTION\INJECTION\INSULIN LISPRO RECOMBINANT\rdfq
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 cartridge

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000027516HumalogNDAEli Lilly And Company1998-02-20INSULIN LISPROSUBCUTANEOUSINJECTION, SOLUTIONNDA020563c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685836HumalogNDAPhysicians Total Care, Inc.2007-12-03INSULIN LISPROSUBCUTANEOUSINJECTION, SOLUTION000027516NDA020563ce8354f4-bf07-4923-8755-47f3163662e4

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 Pen Injector

application drug(s)

#idcategory/deprecatedingredient strength(s)dose 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

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7291132 (view patent)2024-08-09NDA020563, NDA018781, NDA019717, NDA021017, NDA021018, NDA205747insulin, isophane / Regular Insulin, Human Injectable Suspension
insulin, isophane Injectable Suspension
Insulin Lispro / Insulin, Protamine Lispro, Human Injectable Suspension
Insulin Lispro Injectable Solution
Insulin Lispro Pen Injector
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 Company2015-08-0448000027516, 000027510, 000027712, 000028799Insulin Lispro Injectable Solution
Insulin Lispro Pen Injector
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.relabel2012-05-223548685836, 548685108, 548685899Insulin Lispro Injectable Solution
Insulin Lispro Pen Injector

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