Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204370

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VRAYLAR (CARIPRAZINE HYDROCHLORIDE)
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)
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)
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)
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