Guanfacine Hydrochloride

ANDA 202578, held by Pharmobedient. Guanfacine Hydrochloride.

As of Nov 15, 2026, ANDA 202578 (Guanfacine Hydrochloride), held by Pharmobedient, was first approved by FDA on Jun 2, 2015, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 2, 2015
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 2, 2015	Original application	Approved	Letter

Products

4 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Jul 18, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jul 18, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jul 18, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jul 18, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 202578
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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