Application 021463

Type: NDA
Sponsor: ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORTESTA	TESTOSTERONE	GEL, METERED;TRANSDERMAL	10MG/0.5GM ACTUATION	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-7831	Testosterone	Testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0603-7831	Testosterone	Testosterone	Par Pharmaceutical	NDA AUTHORIZED GENERIC	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
63481-183	FORTESTA	testosterone	Endo Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82870	SUPPL	2025-07-15
82842	SUPPL	2025-07-14
82841	SUPPL	2025-07-14
63779	SUPPL	2020-07-02
63778	SUPPL	2020-07-02
63766	SUPPL	2020-07-01
62153	SUPPL	2020-03-17
62144	SUPPL	2020-03-16
58914	SUPPL	2019-06-03
58744	SUPPL	2019-05-16
58743	SUPPL	2019-05-16
58659	SUPPL	2019-05-13
45761	SUPPL	2016-11-01
45754	SUPPL	2016-11-01
45674	SUPPL	2016-10-27
37008	SUPPL	2015-05-13
27867	SUPPL	2015-05-13
27866	SUPPL	2014-08-01
27865	SUPPL	2014-06-23
15536	SUPPL	2014-06-23
37007	SUPPL	2014-03-25
27864	SUPPL	2014-03-25
27863	SUPPL	2013-09-11
15535	SUPPL	2013-09-11
24202	ORIG	2011-09-16
21673	ORIG	2011-09-16
23268	ORIG	2011-01-13
37006	ORIG	2011-01-11
44478	ORIG	2011-01-07
5457	ORIG	2011-01-07