← FDA DRUG APPROVALS

FDA NDA · NDA022037

INTUNIV

guanfacine

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022037
TYPE
NDA
ORIGINAL APPROVAL
2009-09-02
LATEST ACTION
2019-12-27
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

INTUNIV · ReferencePrescription
GUANFACINE HYDROCHLORIDE EQ 3MG BASE · TABLET, EXTENDED RELEASE · ORAL
INTUNIV · ReferencePrescription
GUANFACINE HYDROCHLORIDE EQ 1MG BASE · TABLET, EXTENDED RELEASE · ORAL
INTUNIV · ReferencePrescription
GUANFACINE HYDROCHLORIDE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL
INTUNIV · ReferencePrescription
GUANFACINE HYDROCHLORIDE EQ 2MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2019-12-27Labeling · Supplement 19 · standard — Label ↗AP
2019-04-30Labeling · Supplement 18 · standard — Label ↗AP
2018-03-07Labeling · Supplement 16 · standard — Label ↗AP
2017-11-27Labeling · Supplement 14 · standard — Label ↗AP
2016-07-07Labeling · Supplement 13 · standard — Letter ↗AP
2015-03-18Efficacy · Supplement 11 · standard — Pediatric Medical Review ↗AP
2014-11-19Efficacy · Supplement 10 · priority — Label ↗AP
2013-08-23Labeling · Supplement 9 · standard — Label ↗AP
2013-02-20Efficacy · Supplement 8 · standard — Letter ↗AP
2011-06-08Labeling · Supplement 6 · unknown — Label ↗AP
2011-02-25Efficacy · Supplement 2 · standard — Label ↗AP
2009-09-02Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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