insulin detemir Pen Injector

Brand(s)
Levemir
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2015-02-25)
Oldest Current Product
2006-03-27
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN DETEMIR
FDAOB
SUBCUTANEOUS\INJECTION\INSULIN DETEMIR RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN DETEMIR
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\INSULIN DETEMIR

product(s) by strength(s)

3 ml insulin detemir 100 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001696439LevemirNDANovo Nordisk2006-03-272016-11-30INSULIN DETEMIRSUBCUTANEOUSINJECTION, SOLUTIONNDA021536d38d65c1-25bf-401d-9c7e-a2c3222da8af

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685883LevemirNDAPhysicians Total Care, Inc.2008-03-31INSULIN DETEMIRSUBCUTANEOUSINJECTION, SOLUTION001696439NDA021536eae6fcac-02a9-4d7c-8445-03a647b6b59b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1NDA021536LEVEMIRNOVO NORDISK INC2005-06-16p9132239, SUBSTANCE
p7686786, SUBSTANCE
p8684969, SUBSTANCE
p5866538, SUBSTANCE
p8672898, SUBSTANCE
p6899699, SUBSTANCE
p8920383, SUBSTANCE
p6004297, SUBSTANCE
pRE43834, SUBSTANCE
pRE41956, SUBSTANCE
p9108002, SUBSTANCE
p5750497, LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH DIABETES MELLITUS, SUBSTANCE
REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842 [2015-04-06]
ADDITION OF RESULTS OF PEDIATRIC TRIAL TO LABEL [2015-05-18]
NDA021536_001, NDA021536_002, NDA021536_003, NDA021536_004, NDA021536_005insulin detemir Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021536_001RXINSULIN DETEMIR RECOMBINANT (1000 UNITS/10ML)SUBCUTANEOUSINJECTIONTrue2005-06-16LEVEMIR
2NDA021536_002RXINSULIN DETEMIR RECOMBINANT (300 UNITS/3ML)SUBCUTANEOUSINJECTIONTrue2005-06-16LEVEMIR
3NDA021536_003discontinuedINSULIN DETEMIR RECOMBINANT (300 UNITS/3ML)SUBCUTANEOUSINJECTIONFalse2005-06-16LEVEMIR
4NDA021536_004discontinuedINSULIN DETEMIR RECOMBINANT (300 UNITS/3ML)SUBCUTANEOUSINJECTIONFalse2005-06-16LEVEMIR
5NDA021536_005RXINSULIN DETEMIR RECOMBINANT (300 UNITS/3ML)SUBCUTANEOUSINJECTIONTrue2013-10-31LEVEMIR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5750497 (view patent)2019-06-16NDA021536insulin detemir Injectable Solution
2p5866538 (view patent)2017-06-20NDA021536, NDA020986, NDA021172, NDA021810, NDA203313Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
3p6004297 (view patent)2019-01-28NDA021536, NDA020986, NDA021148, NDA021172, NDA022341Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
4p6899699 (view patent)2022-01-02NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
5p7686786 (view patent)2026-08-03NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
6p8672898 (view patent)2022-01-02NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
7p8684969 (view patent)2025-10-20NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
8p8920383 (view patent)2026-07-17NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
9p9108002 (view patent)2026-01-20NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
10p9132239 (view patent)2032-02-01NDA021536, NDA020986, NDA021148, NDA203313, NDA203314, NDA206321insulin degludec Pen Injector
Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
11pRE41956 (view patent)2021-01-21NDA021536, NDA020986, NDA021148, NDA021172, NDA022341Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
12pRE43834 (view patent)2019-01-28NDA021536, NDA020986, NDA021148, NDA021172, NDA022341Insulin, Aspart, Human Cartridge
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1d38d65c1-25bf-401d-9c7e-a2c3222da8af (view SPL)These highlights do not include all the information needed to use LEVEMIR safely and effectively.See full prescribing information for LEVEMIR.LEVEMIR (insulin detemir [rDNA origin] injection) solution for subcutaneous injectionInitial U.S. Approval: 2005prescriptionHuman PrescriptionNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-02-2515001696439, 001693687, 001696438insulin detemir Injectable Solution
2eae6fcac-02a9-4d7c-8445-03a647b6b59b (view SPL)These highlights do not include all the information needed to use LEVEMIR safely and effectively.See full prescribing information for LEVEMIR.LEVEMIR (insulin detemir [rDNA origin] injection) solution for subcutaneous injectionInitial U.S. Approval: 2005prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-03-022548685883

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