Application 090774

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 20MG BASE	No	No
002	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 30MG BASE	No	No
003	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7894	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7895	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8203	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8203	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8203	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8203	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8204	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8204	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8204	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8204	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8290	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8290	Duloxetine hydrochloride	Duloxetin hydrochloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-109	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-110	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
13668-111	Duloxetine hydrochloride	Duloxetin hydrochloride	Torrent Pharmaceuticals Limited	ANDA	Current
63187-457	Duloxetine hydrochloride	Duloxetin hydrochloride	Proficient Rx LP	ANDA	Current
63187-457	Duloxetine hydrochloride	Duloxetin hydrochloride	Proficient Rx LP	ANDA	Current
63187-457	Duloxetine hydrochloride	Duloxetin hydrochloride	Proficient Rx LP	ANDA	Current
64725-1100	Duloxetine hydrochloride	Duloxetin hydrochloride	TYA Pharmaceuticals	ANDA	Current
70518-0363	Duloxetine hydrochloride	Duloxetin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1272	Duloxetine hydrochloride	Duloxetin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1272	Duloxetine hydrochloride	Duloxetin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1273	Duloxetine hydrochloride	Duloxetin hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1273	Duloxetine hydrochloride	Duloxetin hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9292	ORIG	2013-12-13

Application 090774

Related Records#

Application Products#

NDC Listings For This Application#

Documents#