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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEUPROLIDE ACETATELEUPROLIDE ACETATEEndo USA, Inc.290b0716-2fd5-43a1-8d3c-4857c1b2eefa2024-06-10Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
FensolviLEUPROLIDE ACETATETOLMAR Inc.dfb6e01c-f138-471d-bf5b-2be38247e3f02022-04-28Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE
ELIGARDLEUPROLIDE ACETATETOLMAR Inc.b78d1919-9dee-44fa-90f9-e0a26d32481d2019-04-29Warnings, Adverse reactionsName fallback
generic name: LEUPROLIDE ACETATE

Reported adverse events (FAERS/openFDA)#

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

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