Application 090694

Type: ANDA
Sponsor: LUPIN LTD

Related Records

Company: LUPIN LTD

Application Products

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 40MG BASE	No	No
004	DULOXETINE HYDROCHLORIDE	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS;ORAL	EQ 60MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
27437-298	Irenka	Duloxetine	LUPIN PHARMA	ANDA	Current
50090-6281	Duloxetine	Duloxetine	A-S Medication Solutions	ANDA	Current
55154-4980	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4980	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4980	Duloxetine	Duloxetine	Cardinal Health 107, LLC	ANDA	Current
55154-4980	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4980	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4981	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4981	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4981	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
55154-4981	Duloxetine	Duloxetine	Cardinal Health 107, LLC	ANDA	Current
55154-4981	Duloxetine	Duloxetine	Cardinal Health	ANDA	Current
68084-675	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-675	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-675	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-675	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-683	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-683	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-683	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-683	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-692	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-692	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-692	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68084-692	Duloxetine	Duloxetine	American Health Packaging	ANDA	Current
68180-294	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-294	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-294	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-294	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-295	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-295	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-295	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-295	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-296	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-296	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-296	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-296	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-297	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-297	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-297	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-297	Duloxetine	Duloxetine	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-1244	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current
70518-1244	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current
70518-1765	Duloxetine	Duloxetine	REMEDYREPACK INC.	ANDA	Current

Documents

Document	Submission type	Date
31488	ORIG	2013-12-13