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

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PharmaCompass

01

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GUANFACINE HYDROCHLORIDE

Brand Name : TENEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1986-10-27

Application Number : 19032

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Dr. Reddy Company Banner

02

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GUANFACINE HYDROCHLORIDE

Brand Name : TENEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-11-07

Application Number : 19032

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Dr. Reddy Company Banner

03

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GUANFACINE HYDROCHLORIDE

Brand Name : TENEX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1988-11-07

Application Number : 19032

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr. Reddy Company Banner

04

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GUANFACINE HYDROCHLORIDE

Brand Name : GUANFACINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 1995-10-17

Application Number : 74145

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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GUANFACINE HYDROCHLORIDE

Brand Name : GUANFACINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 2MG BASE

Approval Date : 1995-10-17

Application Number : 74145

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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GUANFACINE HYDROCHLORIDE

Brand Name : GUANFACINE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 1997-02-28

Application Number : 74673

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

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GUANFACINE HYDROCHLORIDE

Brand Name : INTUNIV

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2009-09-02

Application Number : 22037

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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08

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GUANFACINE HYDROCHLORIDE

Brand Name : INTUNIV

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 2MG BASE

Approval Date : 2009-09-02

Application Number : 22037

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

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GUANFACINE HYDROCHLORIDE

Brand Name : INTUNIV

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 3MG BASE

Approval Date : 2009-09-02

Application Number : 22037

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

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GUANFACINE HYDROCHLORIDE

Brand Name : INTUNIV

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2009-09-02

Application Number : 22037

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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