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ACETATEINJECTABLE;INJECTION3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020011-001LUPRON DEPOTLEUPROLIDE ACETATE3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-10-22
N020011-002LUPRON DEPOTLEUPROLIDE ACETATE3.75MGINJECTABLE / INJECTIONRLD, RS1995-10-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020011-001LUPRON DEPOT3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-10-22f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020011-002LUPRON DEPOT3.75MGINJECTABLE / INJECTIONRLD, RS1995-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020011-001LUPRON DEPOT3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-10-22e64feba35796…
2022-09-29 23:25 UTC2022-09N020011-002LUPRON DEPOT3.75MGINJECTABLE / INJECTIONRLD, RS1995-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020011-001LUPRON DEPOT3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**POWDER / INTRAMUSCULARRLD1990-10-22cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020011-002LUPRON DEPOT3.75MGPOWDER / INTRAMUSCULARRLD, RS1995-10-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020011-001LUPRON DEPOT3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD1990-10-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020011-002LUPRON DEPOT3.75MGINJECTABLE / INJECTIONRLD, RS1995-10-26a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.00c486b0-bd7b-4898-834d-8c656e5e73cb2025-09-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 020011
application number: NDA020011
ndc (product): 0074-3641

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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