Product Details for NDA 020639
SEROQUEL (QUETIAPINE FUMARATE)
EQ 25MG BASE
Marketing Status: Prescription
EQ 50MG BASE
Marketing Status: Prescription
EQ 100MG BASE
Marketing Status: Prescription
EQ 200MG BASE
Marketing Status: Prescription
EQ 300MG BASE
Marketing Status: Prescription
EQ 400MG BASE
Marketing Status: Prescription
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020639
Product Number: 001
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020639
Product Number: 001
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 007
Approval Date: Oct 4, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 007
Approval Date: Oct 4, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 002
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 002
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 003
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 003
Approval Date: Sep 26, 1997
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020639
Product Number: 005
Approval Date: Jul 26, 2000
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020639
Product Number: 005
Approval Date: Jul 26, 2000
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 400MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 006
Approval Date: Oct 4, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
SEROQUEL (QUETIAPINE FUMARATE)
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020639
Product Number: 006
Approval Date: Oct 4, 2005
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020639
Product Number: 004
Approval Date: Dec 20, 1998
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: SEROQUEL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020639
Product Number: 004
Approval Date: Dec 20, 1998
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status: Discontinued
Patent and Exclusivity Information