Application 090749

Type: ANDA
Sponsor: HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0221	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0222	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0223	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0229	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
0054-0230	Quetiapine Fumarate	Quetiapine Fumarate	West-Ward Pharmaceuticals Corp	ANDA	Current
43353-813	Quetiapine Fumarate	Quetiapine Fumarate	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2757	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-067	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-068	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-069	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-070	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply, Inc.	ANDA	Current
51407-071	Quetiapine Fumarate	Quetiapine Fumarate	Golden State Medical Supply	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9291	ORIG	2012-03-29

Application 090749

Related Records#

Application Products#

NDC Listings For This Application#

Documents#