Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 205689, held by Sun Pharm. Guanfacine Hydrochloride.
As of Nov 15, 2026, ANDA 205689 (Guanfacine Hydrochloride), held by Sun Pharm, was first approved by FDA on Nov 16, 2017, with 4 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 |
|---|---|---|---|
| Nov 16, 2017 | Original application | Approved | None posted |
| Guanfacine HydrochlorideEQ 1MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Discontinued |
| Guanfacine HydrochlorideEQ 2MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Discontinued |
| Guanfacine HydrochlorideEQ 3MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Discontinued |
| Guanfacine HydrochlorideEQ 4MG BASE · tablet, extended release;oral | Guanfacine Hydrochloride | Discontinued |
| May 21, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 30, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 30, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 30, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 16, 2017 | Original application | Approved | None posted |
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
