01 3Promius Pharma
02 8Actavis Inc
03 2Ajanta Pharma Limited
04 4Alembic Pharmaceuticals Limited
05 2Amneal Pharmaceuticals
06 8Apotex Inc
07 2Aurobindo Pharma Limited
08 2Epic Pharma. LLC.
09 4Impax Laboratories
10 4JAMP PHARMA
11 4NORVIUM BIOSCIENCE
12 2Rubicon Research
13 8SHIRE PLC
14 4Sandoz B2B
15 4Sun Pharmaceutical Industries Limited
16 6TWi Pharmaceuticals
17 18Takeda Pharmaceutical
18 4Takeda Pharmaceuticals Australia Pty. Ltd.
19 4Teva Pharmaceutical Industries
20 6Unichem Pharmaceuticals USA, Inc
21 8Wanbang Biopharmaceuticals
22 2Xiromed
23 4Yichang Humanwell Pharmaceutical
24 2i3 Pharmaceuticals
01 4Depot tablet
02 4Depottablett
03 4Extended Release Tablet
04 4PROLONGED-RELEASE TABLET
05 6Ret Tabl
06 12TABLET (EXTENDED-RELEASE)
07 52TABLET, EXTENDED RELEASE;ORAL
08 25TABLET;ORAL
09 4Blank
01 13DISCN
02 12Prescription
03 60RX
04 30Blank
01 4APO-GUANFACINE XR
02 70GUANFACINE HYDROCHLORIDE
03 4INTUNIV
04 4INTUNIV XR
05 22Intuniv
06 4JAMP GUANFACINE XR
07 3TENEX
08 4Blank
01 4Australia
02 12Canada
03 4China
04 8Norway
05 4Sweden
06 6Switzerland
07 77USA
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Dosage Strength : EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Dosage Strength : EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 4MG 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 : DISCN
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2015-10-20
Application Number : 202238
Regulatory Info : DISCN
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
Regulatory Info : RX
Registration Country : USA
Brand Name : GUANFACINE HYDROCHLORIDE
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2015-06-02
Application Number : 201382
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 : 2015-06-02
Application Number : 201382
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 : 2015-06-02
Application Number : 201382
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 4MG BASE
Packaging :
Approval Date : 2015-06-02
Application Number : 201382
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 1MG BASE
Packaging :
Approval Date : 2015-06-02
Application Number : 201408
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 : 2015-06-02
Application Number : 201408
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 : 2015-06-02
Application Number : 201408
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 4MG BASE
Packaging :
Approval Date : 2015-06-02
Application Number : 201408
Regulatory Info : RX
Registration Country : USA
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