Clonidine

NDA 22499, held by Tris Pharma Inc. Clonidine.

As of Nov 14, 2026, NDA 22499 (Clonidine), held by Tris Pharma Inc, was first approved by FDA on Dec 3, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 3, 2009
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 3, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
ClonidineEQ 0.09MG BASE/ML · suspension, extended release;oral	Clonidine	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Sep 23, 2010	Supplement 1Labeling	Approved	Letter Label
Dec 3, 2009	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22499
Drugs@FDA: Overview at FDA
Company: Tris Pharma

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