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Approved Drug Products containing Cariprazine HCl listed in the FDA Orange Book. Original Data : FDA Website

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01

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CARIPRAZINE HYDROCHLORIDE

Brand Name : VRAYLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1.5MG BASE

Approval Date : 2015-09-17

Application Number : 204370

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

02

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CARIPRAZINE HYDROCHLORIDE

Brand Name : VRAYLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 3MG BASE

Approval Date : 2015-09-17

Application Number : 204370

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

03

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CARIPRAZINE HYDROCHLORIDE

Brand Name : VRAYLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 4.5MG BASE

Approval Date : 2015-09-17

Application Number : 204370

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

04

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CARIPRAZINE HYDROCHLORIDE

Brand Name : VRAYLAR

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 6MG BASE

Approval Date : 2015-09-17

Application Number : 204370

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Abbvie Company Banner

05

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1.5MG BASE

Approval Date : 2022-09-30

Application Number : 213932

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 3MG BASE

Approval Date : 2022-09-30

Application Number : 213932

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 4.5MG BASE

Approval Date : 2022-09-30

Application Number : 213932

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

08

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 6MG BASE

Approval Date : 2022-09-30

Application Number : 213932

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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09

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1.5MG BASE

Approval Date : 2022-09-09

Application Number : 213984

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

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CARIPRAZINE HYDROCHLORIDE

Brand Name : CARIPRAZINE HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 3MG BASE

Approval Date : 2022-09-09

Application Number : 213984

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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