Home Applications 020011 Application 020011
Type NDA
Sponsor ABBVIE ENDOCRINE INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LUPRON DEPOT LEUPROLIDE ACETATE INJECTABLE;INJECTION 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 002 LUPRON DEPOT LEUPROLIDE ACETATE INJECTABLE;INJECTION 3.75MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020011-001 LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 N020011-002 LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26
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 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020011-001 LUPRON DEPOT 3.75MG/VIAL INJECTABLE / INJECTION RLD 1990-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020011-001 LUPRON DEPOT 3.75MG/VIAL INJECTABLE / INJECTION RLD 1990-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION RLD 1990-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1990-10-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020011-001 LUPRON DEPOT 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE / INJECTION RLD 1990-10-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020011-002 LUPRON DEPOT 3.75MG INJECTABLE / INJECTION RLD, RS 1995-10-26 782e0a99824c…
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current 0074-3641 Lupron Depot leuprolide acetate AbbVie Inc. NDA Current