Application 201504

Type: ANDA
Sponsor: ALKEM LABS LTD

Related Records

Company: ALKEM LABS 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
0904-6638	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6638	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6638	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6638	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6639	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6639	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6639	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6639	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6640	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6640	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6640	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6640	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6641	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6641	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6641	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6641	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6642	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6642	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6642	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6642	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6643	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6643	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6643	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
0904-6643	Quetiapine Fumarate	Quetiapine Fumarate	Major Pharmaceuticals	ANDA	Current
50090-3333	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3333	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3333	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3333	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3333	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3342	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3342	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3342	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3342	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-3351	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-5473	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50090-5884	Quetiapine Fumarate	Quetiapine Fumarate	A-S Medication Solutions	ANDA	Current
50268-630	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-630	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-630	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-631	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-631	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-631	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-632	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-632	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-632	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-633	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-633	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-633	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-634	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-634	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-634	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-635	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-635	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
50268-635	Quetiapine Fumarate	Quetiapine Fumarate	AvPAK	ANDA	Current
55154-3359	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-3359	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-3359	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health 107, LLC	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health 107, LLC	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7881	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health 107, LLC	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-7894	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-8092	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health 107, LLC	ANDA	Current
55154-8092	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-8092	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55154-8092	Quetiapine Fumarate	Quetiapine Fumarate	Cardinal Health	ANDA	Current
55700-903	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-903	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-903	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-903	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-941	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-941	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current
55700-941	Quetiapine Fumarate	Quetiapine Fumarate	Quality Care Products, LLC	ANDA	Current

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