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Last Updated: July 5, 2020

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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. Forty-eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022047
Medical Subject Heading (MeSH) Categories for 022047
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 0310-0280-39 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0310-0280-39)
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)
Paragraph IV (Patent) Challenges for 022047
Tradename Dosage Ingredient NDA Submissiondate
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-11-17
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-10-17
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-06-18
SEROQUEL XR TABLET, EXTENDED RELEASE;ORAL quetiapine fumarate 022047 2008-06-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG BASE
Approval Date:May 17, 2007TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG BASE
Approval Date:May 17, 2007TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 300MG BASE
Approval Date:May 17, 2007TE:ABRLD:Yes

Expired US Patents for NDA 022047

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

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