APPLICATION
NDA018891
TYPE
NDA
ORIGINAL APPROVAL
1984-10-10
LATEST ACTION
2025-12-04
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription
Products
CATAPRES-TTS-3 · ReferencePrescription
CLONIDINE 0.3MG/24HR · SYSTEM · TRANSDERMAL
CATAPRES-TTS-1 · ReferencePrescription
CLONIDINE 0.1MG/24HR · SYSTEM · TRANSDERMAL
CATAPRES-TTS-2 · ReferencePrescription
CLONIDINE 0.2MG/24HR · SYSTEM · TRANSDERMAL
Approval history
1999-08-30Manufacturing (CMC) · Supplement 21 · standardAP
1998-09-22Manufacturing (CMC) · Supplement 20 · standardAP
1997-10-03Manufacturing (CMC) · Supplement 19 · standardAP
1996-09-06Labeling · Supplement 16 · standardAP
1996-07-23Manufacturing (CMC) · Supplement 17 · standardAP
1996-07-23Manufacturing (CMC) · Supplement 18 · standardAP
1995-06-09Manufacturing (CMC) · Supplement 10 · standardAP
1993-02-19Manufacturing (CMC) · Supplement 14 · standardAP
1992-11-24Manufacturing (CMC) · Supplement 13 · standardAP
1992-08-17Manufacturing (CMC) · Supplement 12 · standardAP
1989-12-13Manufacturing (CMC) · Supplement 11 · standardAP
1989-04-18Labeling · Supplement 9AP
1988-12-07Labeling · Supplement 8AP
1988-10-27Manufacturing (CMC) · Supplement 7 · standardAP
1988-07-21Manufacturing (CMC) · Supplement 6 · standardAP
1988-05-11Labeling · Supplement 4AP
1988-05-11Labeling · Supplement 3AP
1987-10-14Manufacturing (CMC) · Supplement 5 · standardAP
1985-09-18Labeling · Supplement 2AP
1985-04-18Labeling · Supplement 1AP
1984-10-10Type 3 - New Dosage Form · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.