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 43.

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	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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019836-001	SUPPRELIN	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019836-002	SUPPRELIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019836-003	SUPPRELIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019836-001	SUPPRELIN	EQ 0.2MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019836-002	SUPPRELIN	EQ 0.5MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019836-003	SUPPRELIN	EQ 1MG BASE/ML	INJECTABLE / INJECTION	1991-12-24	`caaa826d4ba7…`
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…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPPRELIN LA	HISTRELIN ACETATE	Endo USA, Inc.	d8fb000e-3cc9-4803-b71d-2cc597661977	2025-09-25	Warnings, Adverse reactions	Name fallback generic name: HISTRELIN ACETATE

Reported adverse events (FAERS/openFDA)#

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