FDA.reportPublic FDA data

Application 019943

Type
NDA
Sponsor
ABBVIE ENDOCRINE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002LUPRON DEPOTLEUPROLIDE ACETATEINJECTABLE; INJECTION3.75MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leuprolide acetateLEUPROLIDE ACETATEAmneal Pharmaceuticals LLC4838c674-044e-46b2-81e7-c691b99d8fa52026-05-28Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Pharmaceuticals USA Inc.35634415-000f-47db-9bd7-9e16eef3f02e2026-05-25Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Leuprolide AcetateLEUPROLIDE ACETATESandoz Inc8bd72c1e-2751-4498-a346-bc5e3acbba0b2026-05-19Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATELEUPROLIDE ACETATEEugia US LLC49a1d0c1-304c-46f2-a780-bd940ae1ced02026-05-08Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
VabrintyLEUPROLIDE ACETATEURONOVA PHARMACEUTICALS, INC.008776cc-83f1-4f8c-819b-6471425da15f2026-04-30Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
EligardLEUPROLIDE ACETATETOLMAR Inc.b7b679a9-6823-4ef8-8d31-3ab5058ffcfc2026-04-30Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
leuprolide acetateLEUPROLIDE ACETATESun Pharmaceutical Industries, Inc.a3b01473-30c7-4945-bd60-2484221aaaad2026-04-24Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Leuprolide AcetateLEUPROLIDE ACETATEMeitheal Pharmaceuticals Incd6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa5842026-04-23Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
leuprolide acetateLEUPROLIDE ACETATEUBI Pharma Inc.cd46628f-055f-4da9-8c38-fa69af34eb4d2026-03-29Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.cbc8f94e-7330-4465-05ad-16d64493a5dd2026-03-15Warnings, Adverse reactionsName fallback
brand name: Lupron Depot
generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Lifesciences Limited4bae0e2a-dd36-4987-85ee-36a52e642ec72026-02-09Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
leuprolide acetateLEUPROLIDE ACETATEPAI Holdings, LLC dba PAI Pharma19be0b7f-e68a-4547-9e49-b51b128219072026-01-16Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Leuprolide AcetateLEUPROLIDE ACETATEVGYAAN Pharmaceuticals LLCbec9077a-3f04-4887-856d-dde2de24584d2025-11-21Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Lupron Depot-PEDLEUPROLIDE ACETATEAbbVie Inc.e99f47d2-da10-3127-ecb3-e5d942ae6e812025-11-14Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
FensolviLEUPROLIDE ACETATETOLMAR Inc.2c311700-edf4-4f2a-a468-9875489a6cc72025-09-25Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.00c486b0-bd7b-4898-834d-8c656e5e73cb2025-09-18Warnings, Adverse reactionsName fallback
brand name: Lupron Depot
generic name: LEUPROLIDE ACETATE
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.60aad237-e1da-4705-cbbb-b3ca79e89ad82025-09-10Warnings, Adverse reactionsName fallback
brand name: Lupron Depot
generic name: LEUPROLIDE ACETATE
Leuprolide AcetateLEUPROLIDE ACETATENorthStar RxLLC0cf31b40-816b-d055-e063-6294a90af5d02025-06-24Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
LUTRATE DEPOTLEUPROLIDE ACETATEAvyxa Pharma, LLC3a6d1373-17d9-4289-b62f-d299ffe558312025-06-03Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
LEUPROLIDE ACETATE DEPOTLEUPROLIDE ACETATECIPLA USA INC.1563a30b-66e0-445d-ba3e-1ccd5218133f2024-08-27Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83336SUPPL 2025-09-11
83335SUPPL 2025-09-11
83322SUPPL 2025-09-11
83321SUPPL 2025-09-11
73347SUPPL 2023-01-31
73339SUPPL2023-01-30
66297SUPPL2021-02-18
66216SUPPL2021-02-16
34115SUPPL2013-11-05
1833SUPPL2013-10-31
1831SUPPL2012-04-02
34112SUPPL2012-03-28
1832SUPPL2012-01-25
34114SUPPL2012-01-23
44040ORIG2011-12-20
34113SUPPL2011-06-16
19863SUPPL2011-06-16
19862SUPPL2010-11-02
12082SUPPL2010-10-29
19861SUPPL2009-06-08
34111SUPPL2009-06-04
1830SUPPL2007-11-08
41106SUPPL2007-07-09
41105SUPPL2007-07-09
41104SUPPL2007-07-09
20431SUPPL2007-07-09
20430ORIG2007-07-09
1829SUPPL2005-10-20
1828SUPPL2005-10-20
19859SUPPL2004-01-22
19860SUPPL2004-01-14