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Details for New Drug Application (NDA): 204370

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NDA 204370 describes VRAYLAR, which is a drug marketed by Forest Res Inst Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VRAYLAR profile page.

The generic ingredient in VRAYLAR is cariprazine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cariprazine hydrochloride profile page.

Summary for NDA: 204370

Tradename:
VRAYLAR
Applicant:
Forest Res Inst Inc
Ingredient:
cariprazine hydrochloride
Patents:2
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 USA, 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 USA, Inc. 61874-115 61874-115-17 1 BLISTER PACK in 1 CARTON (61874-115-17) > 7 CAPSULE, GELATIN COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Sep 17, 2015TE:RLD:No
Patent:7,943,621Patent Expiration:Dec 16, 2028Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Sep 17, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:7,737,142Patent Expiration:Mar 27, 2027Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE


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