Application 203098

Type: NDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL, METERED;TRANSDERMAL	12.5MG/1.25GM ACTUATION	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	No	No
003	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-116	Testosterone	Testosterone	Perrigo New York Inc	NDA	Current
45802-116	Testosterone	Testosterone	Perrigo New York Inc	NDA	Current
70518-1171	Testosterone	Testosterone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45742	SUPPL	2016-11-01
45680	SUPPL	2016-10-27
24111	ORIG	2015-07-07
40260	SUPPL	2015-05-13
10159	SUPPL	2015-05-13
32371	SUPPL	2014-06-23
19421	SUPPL	2014-06-23
24427	ORIG	2013-06-28
22909	ORIG	2013-06-28
10158	ORIG	2013-02-04
19420	ORIG	2013-02-01