Application 022058

Type: NDA
Sponsor: ENDO PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUPPRELIN LA	HISTRELIN ACETATE	IMPLANT;SUBCUTANEOUS	50MG	Yes	Yes

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022058-001	SUPPRELIN LA	HISTRELIN ACETATE	50MG	IMPLANT / SUBCUTANEOUS		RLD, RS	2007-05-03

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022058-001	8062652	2026-06-16	U-1197

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N022058-001	SUPPRELIN LA	50MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2007-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022058-001	SUPPRELIN LA	50MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2007-05-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022058-001	SUPPRELIN LA	50MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2007-05-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022058-001	SUPPRELIN LA	50MG	IMPLANT / SUBCUTANEOUS	RLD, RS	2007-05-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Source SHA-256
2026-10-15 13:18:30	2026-09	N022058-001	8062652	2026-06-16	U-1197	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022058-001	8062652	2026-06-16	U-1197	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022058-001	8062652	2026-06-16	U-1197	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022058-001	8062652	2026-06-16	U-1197	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022058-001	8062652	2026-06-16	U-1197	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022058-001	8062652	2026-06-16	U-1197	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022058-001	8062652	2026-06-16	U-1197	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022058-001	8062652	2026-06-16	U-1197	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022058-001	8062652	2026-06-16	U-1197	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022058-001	8062652	2026-06-16	U-1197	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022058-001	8062652	2026-06-16	U-1197	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022058-001	8062652	2026-06-16	U-1197	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022058-001	8062652	2026-06-16	U-1197	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022058-001	8062652	2026-06-16	U-1197	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022058-001	8062652	2026-06-16	U-1197	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022058-001	8062652	2026-06-16	U-1197	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022058-001	8062652	2026-06-16	U-1197	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022058-001	8062652	2026-06-16	U-1197	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022058-001	8062652	2026-06-16	U-1197	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022058-001	8062652	2026-06-16	U-1197	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022058-001	8062652	2026-06-16	U-1197	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022058-001	8062652	2026-06-16	U-1197	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022058-001	8062652	2026-06-16	U-1197	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022058-001	8062652	2026-06-16	U-1197	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022058-001	8062652	2026-06-16	U-1197	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022058-001	8062652	2026-06-16	U-1197	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022058-001	8062652	2026-06-16	U-1197	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022058-001	8062652	2026-06-16	U-1197	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022058-001	8062652	2026-06-16	U-1197	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022058-001	8062652	2026-06-16	U-1197	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022058-001	8062652	2026-06-16	U-1197	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022058-001	8062652	2026-06-16	U-1197	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022058-001	8062652	2026-06-16	U-1197	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022058-001	8062652	2026-06-16	U-1197	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022058-001	8062652	2026-06-16	U-1197	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022058-001	8062652	2026-06-16	U-1197	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022058-001	8062652	2026-06-16	U-1197	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022058-001	8062652	2026-06-16	U-1197	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022058-001	8062652	2026-06-16	U-1197	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022058-001	8062652	2026-06-16	U-1197	`3a93d1ddd44b…`

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	Exact identifier application applno (NDA): 022058 application number: NDA022058 ndc (product): 67979-002

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67979-002	SUPPRELIN	histrelin acetate	Endo Pharmaceuticals Inc.	NDA	Current
67979-002	SUPPRELIN	histrelin acetate	Endo Pharmaceuticals Solutions Inc.	NDA	Current
67979-002	SUPPRELIN	histrelin acetate	Endo Pharmaceuticals Inc.	NDA	Current
67979-002	SUPPRELIN	histrelin acetate	Endo Pharmaceuticals Inc.	NDA	Current
67979-002	SUPPRELIN	histrelin acetate	Endo Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83462	SUPPL	2025-09-25
83461	SUPPL	2025-09-25
83425	SUPPL	2025-09-24
70825	SUPPL	2022-04-27
70824	SUPPL	2022-04-27
70810	SUPPL	2022-04-26
60825	SUPPL	2019-11-13
60823	SUPPL	2019-11-12
60822	SUPPL	2019-11-12
48493	SUPPL	2017-05-23
48492	SUPPL	2017-05-23
48474	SUPPL	2017-05-22
48473	SUPPL	2017-05-22
48472	SUPPL	2017-05-22
48471	SUPPL	2017-05-19
38160	SUPPL	2016-07-13
38161	SUPPL	2013-04-09
6790	SUPPL	2013-04-03
16860	SUPPL	2012-04-06
6789	SUPPL	2012-04-06
16859	SUPPL	2011-11-18
29169	SUPPL	2011-11-02
24238	ORIG	2008-12-02
21922	ORIG	2008-12-02
38159	SUPPL	2008-07-09
29168	SUPPL	2008-07-08
29167	SUPPL	2007-11-26
6788	ORIG	2007-05-09
38158	ORIG	2007-05-07