Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022037
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INTUNIV GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
INTUNIV GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
INTUNIV GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes No
INTUNIV GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/02/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022037s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037_intuniv_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022037s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/30/2019 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022037s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022037Orig1s018ltr.pdf
03/07/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022037s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022037Orig1s016ltr.pdf
11/27/2017 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022037s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022037Orig1s014ltr.pdf
07/07/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022037s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022037Orig1s013ltr.pdf
03/18/2015 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022037s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022037Orig1s011ltr.pdf
11/19/2014 SUPPL-10 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022037s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022037Orig1s010ltr.pdf
08/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s009ltr.pdf
02/20/2013 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022037Orig1s008ltr.pdf
06/08/2011 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s006ltr.pdf
02/25/2011 SUPPL-2 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022037s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/30/2019 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022037s018lbl.pdf
03/07/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022037s016lbl.pdf
11/27/2017 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022037s014lbl.pdf
07/07/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022037s013lbl.pdf
03/18/2015 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022037s011lbl.pdf
11/19/2014 SUPPL-10 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022037s010lbl.pdf
08/23/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s009lbl.pdf
02/20/2013 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022037s008lbl.pdf
06/08/2011 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s006lbl.pdf
02/25/2011 SUPPL-2 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022037s002lbl.pdf
09/02/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022037lbl.pdf

INTUNIV

TABLET, EXTENDED RELEASE;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
INTUNIV GUANFACINE HYDROCHLORIDE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

TABLET, EXTENDED RELEASE;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
INTUNIV GUANFACINE HYDROCHLORIDE EQ 2MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

TABLET, EXTENDED RELEASE;ORAL; EQ 3MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
INTUNIV GUANFACINE HYDROCHLORIDE EQ 3MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 200881 ACTAVIS ELIZABETH
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205430 APOTEX INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 202568 SANDOZ INC
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205689 SUN PHARM
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201382 TEVA PHARMS USA
GUANFACINE HYDROCHLORIDE GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201408 TWI PHARMS
INTUNIV GUANFACINE HYDROCHLORIDE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022037 SHIRE

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