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01 3Promius Pharma
02 8Actavis Inc
03 2AiPing Pharmaceutical Inc
04 2Ajanta Pharma Limited
05 4Alembic Pharmaceuticals Limited
06 2Amneal Pharmaceuticals
07 8Apotex Inc
08 2Aurobindo Pharma Limited
09 2Epic Pharma. LLC.
10 4Fosun Wanbang Pharmaceutical
11 4Impax Laboratories
12 4JAMP PHARMA
13 7Neuraxpharm
14 4PHARMOBEDIENT
15 6Rubicon Research
16 4SHIRE PLC
17 4Sandoz B2B
18 4Sun Pharmaceutical Industries Limited
19 4TWi Pharmaceuticals
20 20Takeda Pharmaceutical
21 4Takeda Pharmaceuticals Australia Pty. Ltd.
22 4Teva Pharmaceutical Industries
23 6Unichem Pharmaceuticals USA, Inc
24 4Wanbang Biopharmaceuticals
25 2Xiromed
26 4Yichang Humanwell Pharmaceutical
27 2i3 Pharmaceuticals
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01 4Depot tablet
02 4Depottablett
03 8Extended Release Tablet
04 12TABLET (EXTENDED-RELEASE)
05 56TABLET, EXTENDED RELEASE;ORAL
06 25TABLET;ORAL
07 11Tablet
08 4Blank
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01 4Allowed
02 11Approved
03 13DISCN
04 68RX
05 28Blank
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01 4APO-GUANFACINE XR
02 74GUANFACINE HYDROCHLORIDE
03 4INTUNIV
04 4INTUNIV XR
05 20Intuniv
06 4JAMP GUANFACINE XR
07 7Paxneury
08 3TENEX
09 4Blank
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01 4Australia
02 12Canada
03 4China
04 8Norway
05 11Sweden
06 4Switzerland
07 81USA
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1986-10-27
Application Number : 19032
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1988-11-07
Application Number : 19032
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
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Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 1988-11-07
Application Number : 19032
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 1995-10-17
Application Number : 74145
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 1995-10-17
Application Number : 74145
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 1997-06-25
Application Number : 74762
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 1997-06-25
Application Number : 74762
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2012-10-05
Application Number : 200881
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 2012-10-05
Application Number : 200881
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 3MG BASE
Packaging :
Approval Date : 2012-10-05
Application Number : 200881
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 1998-11-25
Application Number : 75109
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 1998-11-25
Application Number : 75109
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 1997-01-27
Application Number : 74796
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 1997-01-27
Application Number : 74796
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 1997-02-28
Application Number : 74673
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 1997-02-28
Application Number : 74673
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INTUNIV
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2009-09-02
Application Number : 22037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INTUNIV
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 2MG BASE
Packaging :
Approval Date : 2009-09-02
Application Number : 22037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INTUNIV
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 3MG BASE
Packaging :
Approval Date : 2009-09-02
Application Number : 22037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INTUNIV
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 4MG BASE
Packaging :
Approval Date : 2009-09-02
Application Number : 22037
Regulatory Info : RX
Registration Country : USA