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Last Updated: May 24, 2024

Details for New Drug Application (NDA): 204370


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NDA 204370 describes VRAYLAR, which is a drug marketed by Abbvie and is included in one NDA. It is available from two suppliers. There are five patents protecting this drug. Additional details are available on the VRAYLAR profile page.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.
Summary for 204370
Tradename:VRAYLAR
Applicant:Abbvie
Ingredient:cariprazine hydrochloride
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 204370
Suppliers and Packaging for NDA: 204370
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370 NDA Allergan, Inc. 61874-115 61874-115-07 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK (61874-115-07)
VRAYLAR cariprazine hydrochloride CAPSULE;ORAL 204370 NDA Allergan, Inc. 61874-115 61874-115-17 1 BLISTER PACK in 1 CARTON (61874-115-17) / 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Sep 17, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 16, 2025
Regulatory Exclusivity Use:ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS
Patent:⤷  Sign UpPatent Expiration:Sep 17, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
Patent:⤷  Sign UpPatent Expiration:Sep 17, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE

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