Application 022058

Type: NDA
Sponsor: ENDO PHARM

Related Records

Company: ENDO PHARM

Application Products

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

NDC Listings For This Application

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
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