Clonidine

Treats hypertension. ANDA 76166, held by Mylan Technologies. Clonidine.

As of Nov 14, 2026, ANDA 76166 (Clonidine), held by Mylan Technologies, was first approved by FDA on Jul 16, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 16, 2010
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 16, 2010	Original application	Approved	None posted

Products

3 strengths and forms


Clonidine0.1MG/24HR · system;transdermal	Clonidine	Rx
Clonidine0.2MG/24HR · system;transdermal	Clonidine	Rx
Clonidine0.3MG/24HR · system;transdermal	Clonidine	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 27, 2023	Supplement 19Labeling · Standard review	Approved	None posted
May 18, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Aug 24, 2010	Supplement 2Labeling	Approved	None posted
Jul 16, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 76166
Drugs@FDA: Overview at FDA
Company: Mylan Technologies

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