FDA.reportPublic FDA data

Application 020517

Type
NDA
Sponsor
ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION22.5MG/VIALYesNo
002LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION30MG/VIALYesYes
003LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION45MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3346Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3346Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3346Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3346Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3346Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3473Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3473Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3473Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3473Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3473Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3683Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3683Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3683Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3683Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3683Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83147SUPPL 2025-08-20
83133SUPPL 2025-08-19
77927SUPPL 2024-03-25
77917SUPPL 2024-03-22
76734SUPPL 2023-12-05
76730SUPPL 2023-12-05
70794SUPPL2022-04-20
70791SUPPL2022-04-19
57914SUPPL2019-03-07
57892SUPPL2019-03-05
57143SUPPL2019-01-09
56833SUPPL2018-12-20
12671SUPPL2016-06-13
25091SUPPL2016-06-08
41409SUPPL2015-01-20
41408SUPPL2015-01-20
20695SUPPL2015-01-20
34747SUPPL2014-07-01
25090SUPPL2014-07-01
2649SUPPL2013-07-12
12670SUPPL2013-07-11
2648SUPPL2012-07-20
12669SUPPL2012-07-19
23581ORIG2011-12-20
25087SUPPL2011-06-29
2647SUPPL2011-06-29
2646SUPPL2011-06-29
34746SUPPL2011-06-28
34744SUPPL2011-06-28
12668SUPPL2011-06-28
25089SUPPL2011-01-20
12667SUPPL2011-01-20
34745SUPPL2010-05-07
12666SUPPL2010-05-07
12665SUPPL2010-05-07
25088SUPPL2010-05-04
25086SUPPL2010-05-04
2645SUPPL2010-05-04
41407SUPPL2007-07-09
41406SUPPL2007-07-09
20694SUPPL2007-07-09
20692ORIG2006-04-06
41405SUPPL2006-03-30
25085SUPPL2005-10-20
2644SUPPL2005-10-20
2643SUPPL2004-01-14
25084SUPPL2003-09-25
20693SUPPL1997-05-30