Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Pen Injector

Brand(s)
NovoLog Mix
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2015-04-17)
Oldest Current Product
2002-09-11
License(s)
NDA
RxNORM
PEN INJECTOR\INSULIN, ASPART PROTAMINE, HUMAN:INSULIN, ASPART, HUMAN
FDAOB
SUBCUTANEOUS\INJECTION\INSULIN ASPART PROTAMINE RECOMBINANT: INSULIN ASPART RECOMBINANT
SPL Active
SUBCUTANEOUS\INJECTION, SUSPENSION\INSULIN ASPART
SPL Moiety
SUBCUTANEOUS\INJECTION, SUSPENSION\INSULIN ASPART

product(s) by strength(s)

3 ml insulin, aspart protamine, human 70 unt/ml / insulin, aspart, human 30 unt/ml pen injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001693696NovoLog MixNDANovo Nordisk2002-09-11INSULIN ASPARTSUBCUTANEOUSINJECTION, SUSPENSIONNDA0211721861fcee-7673-4afe-a206-08fa05c0add2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685327NovoLog MixNDAPhysicians Total Care, Inc.2011-05-17INSULIN ASPARTSUBCUTANEOUSINJECTION, SUSPENSION001693696NDA021172973a9333-fec7-46dd-8eb5-25738f06ee54

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drugin other drug docs
1NDA021172NOVOLOG MIX 70/30NOVO NORDISK INC2001-11-01p5866538, SUBSTANCE
pRE41956, SUBSTANCE
p6004297, SUBSTANCE
pRE43834, SUBSTANCE
NDA021172_001, NDA021172_002, NDA021172_003, NDA021172_004Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
2NDA021810NOVOLOG MIX 50/50TrueNOVO NORDISK INC2008-08-26p5866538, SUBSTANCENDA021810_001Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021172_001RXINSULIN ASPART RECOMBINANT (300 UNITS/10ML), INSULIN ASPART PROTAMINE RECOMBINANT (700 UNITS/10ML)SUBCUTANEOUSINJECTIONTrue2001-11-01NOVOLOG MIX 70/30
2NDA021172_002discontinuedINSULIN ASPART RECOMBINANT (90 UNITS/3ML), INSULIN ASPART PROTAMINE RECOMBINANT (210 UNITS/3ML)SUBCUTANEOUSINJECTIONFalse2001-11-01NOVOLOG MIX 70/30
3NDA021172_003discontinuedINSULIN ASPART RECOMBINANT (90 UNITS/3ML), INSULIN ASPART PROTAMINE RECOMBINANT (210 UNITS/3ML)SUBCUTANEOUSINJECTIONFalse2001-11-01NOVOLOG MIX 70/30
4NDA021172_004RXINSULIN ASPART PROTAMINE RECOMBINANT (210 UNITS/3ML), INSULIN ASPART RECOMBINANT (90 UNITS/3ML)SUBCUTANEOUSINJECTIONTrue2002-05-03NOVOLOG MIX 70/30
5NDA021810_001discontinuedINSULIN ASPART RECOMBINANT (50 UNITS/ML), INSULIN ASPART PROTAMINE RECOMBINANT (50 UNITS/ML)SUBCUTANEOUSINJECTIONFalse2008-08-26NOVOLOG MIX 50/50

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5866538 (view patent)2017-06-20NDA021172, NDA021810, NDA020986, NDA021536, NDA203313Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
2p6004297 (view patent)2019-01-28NDA021172, NDA020986, NDA021148, NDA021536, NDA022341Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
3pRE41956 (view patent)2021-01-21NDA021172, NDA020986, NDA021148, NDA021536, NDA022341Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
4pRE43834 (view patent)2019-01-28NDA021172, NDA020986, NDA021148, NDA021536, NDA022341Insulin, Aspart, Human Cartridge
insulin detemir Pen Injector
Insulin, Aspart, Human Pen Injector
Somatropin Injectable Solution
Somatropin Prefilled Syringe
liraglutide Pen Injector
insulin detemir Injectable Solution
Insulin, Aspart, Human Injectable Solution
Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11861fcee-7673-4afe-a206-08fa05c0add2 (view SPL)These highlights do not include all the information needed to use NovoLog Mix 70/30 safely and effectively. See full prescribing information for NovoLog Mix 70/30. NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin])Suspension for subcutaneous injectionInitial U.S. Approval: 2001prescriptionHuman PrescriptionNovo NordiskAPI MANUFACTURE, MANUFACTURE2015-04-1716001693696, 001693685Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension
2973a9333-fec7-46dd-8eb5-25738f06ee54 (view SPL)These highlights do not include all the information needed to use NovoLog Mix 70/30 safely and effectively. See full prescribing information for NovoLog Mix 70/30. NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) Suspension for subcutaneous injection Initial U.S. Approval: 2001prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-11-082548685327, 548685201Insulin, Aspart Protamine, Human / Insulin, Aspart, Human Injectable Suspension

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