FDA.reportPublic FDA data

Application 021088

Type
NDA
Sponsor
ORTHO MCNEIL JANSSEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIADURLEUPROLIDE ACETATEIMPLANT;IMPLANTATIONEQ 65MG BASENoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021088-001VIADURLEUPROLIDE ACETATEEQ 65MG BASEIMPLANT / IMPLANTATION2000-03-03

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021088-001VIADUREQ 65MG BASEIMPLANT / IMPLANTATION2000-03-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021088-001VIADUREQ 65MG BASEIMPLANT / IMPLANTATION2000-03-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021088-001VIADUREQ 65MG BASEIMPLANT / IMPLANTATION2000-03-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021088-001VIADUREQ 65MG BASEIMPLANT / IMPLANTATION2000-03-03a50c72e98297…

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
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
generic name: LEUPROLIDE ACETATE
Lupron DepotLEUPROLIDE ACETATEAbbVie Inc.60aad237-e1da-4705-cbbb-b3ca79e89ad82025-09-10Warnings, Adverse reactionsName fallback
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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44095ORIG2011-12-20
26754SUPPL2011-01-20
14375SUPPL2011-01-20
36103SUPPL2005-09-22
26753SUPPL2005-09-22
26751SUPPL2005-09-14
14374SUPPL2005-09-14
26752SUPPL2003-08-15
36102ORIG2000-03-03
26750ORIG2000-03-03
21445ORIG2000-03-03