FDA — authorised 30 September 1974
- Application: ANDA084285
- Marketing authorisation holder: LANNETT
- Indication: Labeling
- Status: approved
🇺🇸 DICYCLOMINE in United States
FDA authorised DICYCLOMINE on 30 September 1974
Marketing authorisations
FDA — authorised 17 August 1976
- Application: ANDA085223
- Marketing authorisation holder: WATSON LABS
- Status: supplemented
FDA — authorised 28 February 1997
- Application: ANDA040204
- Marketing authorisation holder: WEST WARD
- Status: supplemented
FDA — authorised 26 February 1999
- Application: ANDA040230
- Marketing authorisation holder: LANNETT
- Status: supplemented
FDA — authorised 27 December 2017
- Application: ANDA040169
- Marketing authorisation holder: PH HEALTH
- Indication: Labeling
- Status: approved
FDA — authorised 24 March 2023
- Application: ANDA216639
- Marketing authorisation holder: COREPHARMA
- Status: approved
FDA — authorised 30 August 2023
- Application: ANDA217531
- Marketing authorisation holder: PRINSTON INC
- Status: approved
FDA — authorised 7 May 2024
- Application: ANDA217566
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 1 July 2024
- Application: ANDA218018
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
DICYCLOMINE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is DICYCLOMINE approved in United States?
Yes. FDA authorised it on 30 September 1974; FDA authorised it on 17 August 1976; FDA authorised it on 28 February 1997.
Who is the marketing authorisation holder for DICYCLOMINE in United States?
LANNETT holds the US marketing authorisation.