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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020639


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NDA 020639 describes SEROQUEL, which is a drug marketed by Astrazeneca Pharms and Astrazeneca and is included in two NDAs. It is available from three suppliers. Additional details are available on the SEROQUEL profile page.

The generic ingredient in SEROQUEL 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 020639
Tradename:SEROQUEL
Applicant:Astrazeneca Pharms
Ingredient:quetiapine fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020639
Medical Subject Heading (MeSH) Categories for 020639
Suppliers and Packaging for NDA: 020639
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEROQUEL quetiapine fumarate TABLET;ORAL 020639 NDA AstraZeneca Pharmaceuticals LP 0310-0271 0310-0271-10 100 TABLET, FILM COATED in 1 BOTTLE (0310-0271-10)
SEROQUEL quetiapine fumarate TABLET;ORAL 020639 NDA AstraZeneca Pharmaceuticals LP 0310-0272 0310-0272-10 100 TABLET, FILM COATED in 1 BOTTLE (0310-0272-10)
Paragraph IV (Patent) Challenges for 020639
Tradename Dosage Ingredient NDA Submissiondate
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2007-02-12
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2006-02-21
SEROQUEL TABLET;ORAL quetiapine fumarate 020639 2005-08-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Sep 26, 1997TE:ABRLD:Yes

Expired US Patents for NDA 020639

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