Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022037
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| 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 |
|---|---|---|---|---|---|
| 12/27/2019 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022037s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022037Orig1s019ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/27/2019 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022037s019lbl.pdf | |
| 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 | 217269 | ALEMBIC |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
| 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 |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
| INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 1MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
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 | 217269 | ALEMBIC |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
| 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 |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
| INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 2MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
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 | 217269 | ALEMBIC |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
| 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 |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
| INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 3MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |
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 | 217269 | ALEMBIC |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205430 | APOTEX |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 202568 | SANDOZ |
| 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 |
| GUANFACINE HYDROCHLORIDE | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 213428 | YICHANG HUMANWELL |
| INTUNIV | GUANFACINE HYDROCHLORIDE | EQ 4MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 022037 | TAKEDA PHARMS USA |