Home Applications 019836 Application 019836
Type NDA
Sponsor SHIRE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SUPPRELIN HISTRELIN ACETATE INJECTABLE;INJECTION EQ 0.2MG BASE/ML No No 002 SUPPRELIN HISTRELIN ACETATE INJECTABLE;INJECTION EQ 0.5MG BASE/ML No No 003 SUPPRELIN HISTRELIN ACETATE INJECTABLE;INJECTION EQ 1MG BASE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019836-001 SUPPRELIN HISTRELIN ACETATE EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 N019836-002 SUPPRELIN HISTRELIN ACETATE EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 N019836-003 SUPPRELIN HISTRELIN ACETATE EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24
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 4 · 123 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 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019836-002 SUPPRELIN EQ 0.5MG BASE/ML INJECTABLE / INJECTION 1991-12-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019836-003 SUPPRELIN EQ 1MG BASE/ML INJECTABLE / INJECTION 1991-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019836-001 SUPPRELIN EQ 0.2MG BASE/ML INJECTABLE / INJECTION 1991-12-24 8072bd15b7f6…
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.