Product Details for ANDA 201190
QUETIAPINE FUMARATE (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 25MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 001
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 001
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 002
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 002
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 003
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 003
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 004
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 004
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 300MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 005
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE)
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 300MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 005
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 400MG BASE
Marketing Status: Prescription
Active Ingredient: QUETIAPINE FUMARATE
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 006
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: QUETIAPINE FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A201190
Product Number: 006
Approval Date: Mar 27, 2012
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information