Catapres-Tts-1, Catapres-Tts-2, Catapres-Tts-3

Treats hypertension. NDA 18891, held by Lavipharm. Clonidine.

As of Nov 13, 2026, NDA 18891 (Catapres-Tts-1, Catapres-Tts-2, Catapres-Tts-3), held by Lavipharm, was first approved by FDA on Oct 10, 1984, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 10, 1984
Review: Standard
Supplements approved: 28
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 29 submissions below

Date	Submission	Status	Documents
Oct 10, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Catapres-Tts-10.1MG/24HR · system;transdermal	Clonidine	RxReference drug
Catapres-Tts-20.2MG/24HR · system;transdermal	Clonidine	RxReference drug
Catapres-Tts-30.3MG/24HR · system;transdermal	Clonidine	RxReference drug

All 29 submissions, including labeling and manufacturing supplements


Dec 4, 2025	Supplement 34Manufacturing	Approved	Letter Label
Feb 1, 2023	Supplement 32Labeling · Standard review	Approved	Label Letter Letter
May 31, 2012	Supplement 28Labeling	Approved	Letter Label
Apr 28, 2010	Supplement 27Labeling	Approved	Label Letter
Nov 13, 2009	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 13, 2006	Supplement 24Labeling · Standard review	Approved	Letter
Aug 13, 2004	Supplement 22Labeling · Standard review	Approved	Letter
Aug 30, 1999	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 22, 1998	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 3, 1997	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 6, 1996	Supplement 16Labeling · Standard review	Approved	None posted
Sep 6, 1996	Supplement 15Labeling · Standard review	Approved	Review
Jul 23, 1996	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 23, 1996	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 9, 1995	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 19, 1993	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 24, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 17, 1992	Supplement 12Manufacturing · Standard review	Approved	None posted
Dec 13, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 18, 1989	Supplement 9Labeling	Approved	None posted
Dec 7, 1988	Supplement 8Labeling	Approved	None posted
Oct 27, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 21, 1988	Supplement 6Manufacturing · Standard review	Approved	None posted
May 11, 1988	Supplement 4Labeling	Approved	None posted
May 11, 1988	Supplement 3Labeling	Approved	None posted
Oct 14, 1987	Supplement 5Manufacturing · Standard review	Approved	None posted
Sep 18, 1985	Supplement 2Labeling	Approved	None posted
Apr 18, 1985	Supplement 1Labeling	Approved	None posted
Oct 10, 1984	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18891
Drugs@FDA: Overview at FDA
Company: Lavipharm

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