Product Details for NDA 204370
VRAYLAR (CARIPRAZINE HYDROCHLORIDE)
EQ 1.5MG BASE
Marketing Status: Prescription
EQ 3MG BASE
Marketing Status: Prescription
EQ 4.5MG BASE
Marketing Status: Prescription
EQ 6MG BASE
Marketing Status: Prescription
EQ 1.5MG BASE
Marketing Status: Prescription
Active Ingredient: CARIPRAZINE HYDROCHLORIDE
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204370
Product Number: 001
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
VRAYLAR (CARIPRAZINE HYDROCHLORIDE)
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 1.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N204370
Product Number: 001
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 3MG BASE
Marketing Status: Prescription
Active Ingredient: CARIPRAZINE HYDROCHLORIDE
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 002
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
VRAYLAR (CARIPRAZINE HYDROCHLORIDE)
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 002
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 4.5MG BASE
Marketing Status: Prescription
Active Ingredient: CARIPRAZINE HYDROCHLORIDE
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 003
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
VRAYLAR (CARIPRAZINE HYDROCHLORIDE)
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 4.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 003
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 6MG BASE
Marketing Status: Prescription
Active Ingredient: CARIPRAZINE HYDROCHLORIDE
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 004
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: VRAYLAR
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N204370
Product Number: 004
Approval Date: Sep 17, 2015
Applicant Holder Full Name: ABBVIE INC
Marketing Status: Prescription
Patent and Exclusivity Information