FDA — authorised 3 September 1974
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Status: approved
🇺🇸 Catapres-Tts-1 in United States
FDA authorised Catapres-Tts-1 on 3 September 1974
Marketing authorisations
FDA — authorised 18 August 2009
- Application: ANDA076157
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: CLONIDINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 3 December 2009
- Application: NDA022499
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: CLONIDINE
- Indication: SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 December 2009
- Application: NDA022500
- Marketing authorisation holder: ROSEMONT
- Local brand name: NEXICLON XR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 2010
- Application: ANDA076166
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: CLONIDINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
FDA — authorised 6 May 2014
- Application: ANDA090873
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: CLONIDINE
- Indication: SYSTEM — TRANSDERMAL
- Status: approved
Catapres-Tts-1 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Catapres-Tts-1 approved in United States?
Yes. FDA authorised it on 3 September 1974; FDA authorised it on 18 August 2009; FDA authorised it on 3 December 2009.
Who is the marketing authorisation holder for Catapres-Tts-1 in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.