Product Details for ANDA 213669
BREXPIPRAZOLE (BREXPIPRAZOLE)
0.25MG
Marketing Status: Prescription
0.5MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
3MG
Marketing Status: Prescription
4MG
Marketing Status: Prescription
0.25MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 001
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
BREXPIPRAZOLE (BREXPIPRAZOLE)
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 001
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
0.5MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 002
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
BREXPIPRAZOLE (BREXPIPRAZOLE)
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 002
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
1MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 003
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
BREXPIPRAZOLE (BREXPIPRAZOLE)
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 003
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
2MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 004
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
BREXPIPRAZOLE (BREXPIPRAZOLE)
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 004
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
3MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 005
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
BREXPIPRAZOLE (BREXPIPRAZOLE)
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 005
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
4MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 006
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: BREXPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213669
Product Number: 006
Approval Date: Nov 20, 2023
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status: Prescription
Patent and Exclusivity Information