Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022047

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SEROQUEL XR (QUETIAPINE FUMARATE)
EQ 50MG BASE
Marketing Status: Prescription

Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022047
Product Number: 001
Approval Date: May 17, 2007
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SEROQUEL XR (QUETIAPINE FUMARATE)
EQ 150MG BASE
Marketing Status: Prescription

Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 150MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022047
Product Number: 005
Approval Date: Aug 11, 2008
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SEROQUEL XR (QUETIAPINE FUMARATE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022047
Product Number: 002
Approval Date: May 17, 2007
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SEROQUEL XR (QUETIAPINE FUMARATE)
EQ 300MG BASE
Marketing Status: Prescription

Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022047
Product Number: 003
Approval Date: May 17, 2007
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

SEROQUEL XR (QUETIAPINE FUMARATE)
EQ 400MG BASE
Marketing Status: Prescription

Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: SEROQUEL XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022047
Product Number: 004
Approval Date: May 17, 2007
Applicant Holder Full Name: ASTRAZENECA UK LTD
Marketing Status:  Prescription
Patent and Exclusivity Information