Details for New Drug Application (NDA): 022047

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NDA 022047 describes SEROQUEL XR, which is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. Additional details are available on the SEROQUEL XR profile page.

The generic ingredient in SEROQUEL XR is quetiapine fumarate. There are fifty-three drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the quetiapine fumarate profile page.

Summary for 022047

Tradename:	SEROQUEL XR
Applicant:	Astrazeneca
Ingredient:	quetiapine fumarate
Patents:	0

Pharmacology for NDA: 022047

Medical Subject Heading (MeSH) Categories for 022047

Antipsychotic Agents

Suppliers and Packaging for NDA: 022047

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047	NDA	AstraZeneca Pharmaceuticals LP	0310-0280	0310-0280-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0280-60)
SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047	NDA	AstraZeneca Pharmaceuticals LP	0310-0281	0310-0281-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0310-0281-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	May 17, 2007	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 200MG BASE
Approval Date:	May 17, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 300MG BASE
Approval Date:	May 17, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022047

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-001	May 17, 2007	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-005	Aug 11, 2008	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-002	May 17, 2007	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	⤷ Sign Up	⤷ Sign Up
Astrazeneca	SEROQUEL XR	quetiapine fumarate	TABLET, EXTENDED RELEASE;ORAL	022047-003	May 17, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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