FDA.reportPublic FDA data

Application 020011

Type
NDA
Sponsor
ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE;INJECTION3.75MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent
0074-3641Lupron Depotleuprolide acetateAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83338SUPPL 2025-09-11
83337SUPPL 2025-09-11
83325SUPPL 2025-09-11
83323SUPPL 2025-09-11
73346SUPPL 2023-01-31
73338SUPPL2023-01-30
66296SUPPL2021-02-18
66220SUPPL2021-02-16
12138SUPPL2013-11-05
19939SUPPL2013-10-31
19937SUPPL2012-04-02
34182SUPPL2012-03-28
19938SUPPL2012-01-25
12137SUPPL2012-01-23
44041ORIG2011-12-20
12136SUPPL2011-06-16
1909SUPPL2011-06-16
19936SUPPL2010-11-02
34181SUPPL2010-10-29
1908SUPPL2009-06-08
12135SUPPL2009-06-04
19935SUPPL2007-11-08
1907SUPPL2005-10-20
1906SUPPL2005-10-20
1905SUPPL2004-01-22
19934SUPPL2004-01-14
41119SUPPL2001-11-14
12134SUPPL2001-09-21
1904SUPPL2001-09-21
20447SUPPL2001-08-06
19933SUPPL1998-04-09