FDA.reportPublic FDA data

Application 019732

Type
NDA
Sponsor
ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION7.5MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3642Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3642Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3642Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3642Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3642Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83146SUPPL 2025-08-20
83131SUPPL 2025-08-19
77926SUPPL 2024-03-25
77916SUPPL 2024-03-22
76743SUPPL 2023-12-06
76733SUPPL 2023-12-05
70793SUPPL2022-04-20
70790SUPPL2022-04-19
57915SUPPL2019-03-07
57891SUPPL2019-03-05
57142SUPPL2019-01-09
56831SUPPL2018-12-20
11664SUPPL2016-06-13
1555SUPPL2016-06-08
11663SUPPL2014-07-01
1554SUPPL2014-07-01
1553SUPPL2013-07-12
33893SUPPL2013-07-11
19131SUPPL2012-02-23
11662SUPPL2012-02-22
23552ORIG2011-12-20
11661SUPPL2011-01-20
1552SUPPL2011-01-20
33892SUPPL2010-05-07
11660SUPPL2010-05-07
11659SUPPL2010-05-07
19130SUPPL2010-05-04
19129SUPPL2010-05-04
1551SUPPL2010-05-04
40987SUPPL2006-10-26
40986SUPPL2006-10-26
20306SUPPL2006-10-26
20304SUPPL2006-10-26
20303SUPPL2006-10-26
19128SUPPL2005-10-20
1550SUPPL2005-10-20
19127SUPPL2004-01-14
19126SUPPL2003-09-25
20305SUPPL2003-05-30
11658SUPPL2003-05-30
1549SUPPL2003-05-30