Application 091388

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Related Records

Company: AUROBINDO PHARMA LTD

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 25MG BASE	No	No
002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 50MG BASE	No	No
003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 100MG BASE	No	No
004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 150MG BASE	No	No
005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 200MG BASE	No	No
006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 300MG BASE	No	No
007	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	TABLET;ORAL	EQ 400MG BASE	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-717	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-717	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-717	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-718	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-718	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-718	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-719	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-719	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-719	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-720	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-720	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-720	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-721	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-721	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-721	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-722	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-722	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-722	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-809	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-809	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
16571-809	Quetiapine Fumarate	Quetiapine Fumarate	Rising Pharma Holdings, Inc.	ANDA	Current
48433-324	Quetiapine Fumarate	Quetiapine Fumarate	Safecor Health, LLC	ANDA	Current
57237-079	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
57237-080	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
57237-081	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
57237-082	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
57237-083	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
57237-084	Quetiapine Fumarate	Quetiapine Fumarate	Citron Pharma LLC	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-489	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-490	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-491	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-492	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-493	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-494	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
65862-495	Quetiapine Fumarate	Quetiapine Fumarate	Aurobindo Pharma Limited	ANDA	Current
70518-3429	Quetiapine Fumarate	Quetiapine Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-3581	Quetiapine Fumarate	Quetiapine Fumarate	REMEDYREPACK INC.	ANDA	Current
70518-3609	Quetiapine Fumarate	Quetiapine Fumarate	REMEDYREPACK INC.	ANDA	Current

Documents

Document	Submission type	Date
9336	ORIG	2012-03-30