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

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01 PROMIUS PHARMA (3)

02 SUN PHARM (4)

03 ACTAVIS ELIZABETH (4)

04 AJANTA PHARMA LTD (2)

05 ALEMBIC (4)

06 AMNEAL PHARM (2)

07 APOTEX (4)

08 AUROBINDO PHARMA USA (2)

09 EPIC PHARMA LLC (2)

10 I 3 PHARMS (2)

11 IMPAX LABS INC (4)

12 MYLAN (4)

13 RUBICON (2)

14 SANDOZ (4)

15 TAKEDA PHARMS USA (4)

16 TEVA PHARMS USA (4)

17 TWI PHARMS (6)

18 UNICHEM (2)

19 WATSON LABS (4)

20 XIROMED (2)

21 YICHANG HUMANWELL (4)

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01 TABLET, EXTENDED RELEASE;ORAL (44)

02 TABLET;ORAL (25)

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01 DISCN (13)

02 RX (56)

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01 GUANFACINE HYDROCHLORIDE (62)

02 INTUNIV (4)

03 TENEX (3)

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01 No (63)

02 Yes (6)

URL Supplier Web Content
TABLET;ORAL
EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1986-10-27
19032
TENEX
DISCN
Yes
Dr. Reddy Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1988-11-07
19032
TENEX
DISCN
Yes
Dr. Reddy Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET;ORAL
EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
1988-11-07
19032
TENEX
DISCN
No
Dr. Reddy Company Banner

EMWA 2024

Not Confirmed

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URL Supplier Web Content
TABLET, EXTENDED RELEASE;ORAL
EQ 1MG BASE
2017-11-16
205689
GUANFACINE HYDROCHLORI...
RX
No
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TABLET, EXTENDED RELEASE;ORAL
EQ 2MG BASE
2017-11-16
205689
GUANFACINE HYDROCHLORI...
RX
No
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TABLET, EXTENDED RELEASE;ORAL
EQ 3MG BASE
2017-11-16
205689
GUANFACINE HYDROCHLORI...
RX
No
AB
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TABLET, EXTENDED RELEASE;ORAL
EQ 4MG BASE
2017-11-16
205689
GUANFACINE HYDROCHLORI...
RX
No
AB
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TABLET, EXTENDED RELEASE;ORAL
EQ 1MG BASE
2009-09-02
22037
INTUNIV
RX
Yes
AB
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TABLET, EXTENDED RELEASE;ORAL
EQ 2MG BASE
2009-09-02
22037
INTUNIV
RX
Yes
AB
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TABLET, EXTENDED RELEASE;ORAL
EQ 3MG BASE
2009-09-02
22037
INTUNIV
RX
Yes
AB
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