Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 200881, held by Actavis Elizabeth. Guanfacine Hydrochloride.
As of Nov 14, 2026, ANDA 200881 (Guanfacine Hydrochloride), held by Actavis Elizabeth, was first approved by FDA on Oct 5, 2012, with 5 approved supplements and 0 published complete response letters.
Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2012 | Original application | Approved |
| Guanfacine HydrochlorideEQ 1MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Rx |
| Guanfacine HydrochlorideEQ 2MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Rx |
| Guanfacine HydrochlorideEQ 3MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Rx |
| Guanfacine HydrochlorideEQ 4MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Rx |
| May 21, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 4, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 4, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 30, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 10, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Oct 5, 2012 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
