U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 205422

Expand all

REXULTI (BREXPIPRAZOLE)
0.25MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205422
Product Number: 001
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
REXULTI (BREXPIPRAZOLE)
0.5MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205422
Product Number: 002
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
REXULTI (BREXPIPRAZOLE)
1MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205422
Product Number: 003
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
REXULTI (BREXPIPRAZOLE)
2MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N205422
Product Number: 004
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
REXULTI (BREXPIPRAZOLE)
3MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205422
Product Number: 005
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
REXULTI (BREXPIPRAZOLE)
4MG
Marketing Status: Prescription
Active Ingredient: BREXPIPRAZOLE
Proprietary Name: REXULTI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N205422
Product Number: 006
Approval Date: Jul 10, 2015
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top