FDA.reportPublic FDA data

Application 021318

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FORTEOTERIPARATIDESOLUTION;SUBCUTANEOUS0.75MG/3ML (0.25MG/ML)NoNo
002FORTEOTERIPARATIDESOLUTION;SUBCUTANEOUS0.6MG/2.4ML (0.25MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent
0002-8400ForteoTeriparatideEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79221SUPPL 2024-07-26
71471SUPPL2022-06-28
69647SUPPL2021-12-20
69646SUPPL2021-12-20
68658SUPPL2021-09-20
68563SUPPL2021-09-09
66106SUPPL2021-02-05
65268SUPPL2020-12-01
65261SUPPL2020-11-18
62521SUPPL2020-04-09
62468SUPPL2020-04-07
60231SUPPL2019-10-04
60223SUPPL2019-10-04
48200SUPPL2017-05-02
15178SUPPL2013-09-09
5017SUPPL2013-09-04
27466SUPPL2012-03-15
42097SUPPL2011-10-10
5016SUPPL2011-08-12
36643SUPPL2009-07-23
5013SUPPL2009-07-23
5015SUPPL2008-06-30
15177SUPPL2008-03-05
5014SUPPL2008-03-04
27465SUPPL2007-05-29
15176SUPPL2007-05-29
36642SUPPL2004-09-07
27464SUPPL2004-09-07
15175SUPPL2004-06-07
5012SUPPL2004-06-07
21595ORIG2004-03-24
23253ORIG2003-12-17
27463ORIG2001-11-26
15174ORIG2001-11-26