FDA — authorised 13 January 1998
- Application: ANDA074631
- Marketing authorisation holder: SANDOZ
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cycloset in United States
FDA authorised Cycloset on 13 January 1998
Marketing authorisations
FDA — authorised 30 July 2008
- Application: ANDA078899
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 October 2008
- Application: ANDA077646
- Marketing authorisation holder: PADAGIS US
- Local brand name: BROMOCRIPTINE MESYLATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2009
- Application: NDA020866
- Marketing authorisation holder: VEROSCIENCE
- Status: supplemented
FDA
- Status: approved
Cycloset in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Cycloset approved in United States?
Yes. FDA authorised it on 13 January 1998; FDA authorised it on 30 July 2008; FDA authorised it on 1 October 2008.
Who is the marketing authorisation holder for Cycloset in United States?
SANDOZ holds the US marketing authorisation.