FDA — authorised 8 October 1982
- Application: NDA018658
- Marketing authorisation holder: RB HLTH
- Local brand name: DELSYM
- Indication: SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Delsym in United States
FDA authorised Delsym on 8 October 1982
Marketing authorisations
FDA — authorised 2 April 1984
- Application: NDA011265
- Marketing authorisation holder: ANI PHARMS
- Indication: Efficacy
- Status: approved
FDA — authorised 15 July 2014
- Application: ANDA205292
- Marketing authorisation holder: PADAGIS US
- Status: approved
FDA — authorised 20 September 2016
- Application: ANDA203375
- Marketing authorisation holder: ACELLA
- Status: approved
FDA — authorised 5 March 2018
- Application: ANDA207602
- Marketing authorisation holder: PERRIGO R AND D
- Status: approved
FDA — authorised 31 January 2020
- Application: NDA021620
- Marketing authorisation holder: RB HLTH
- Indication: Manufacturing (CMC)
- Status: approved
Delsym 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 Delsym approved in United States?
Yes. FDA authorised it on 8 October 1982; FDA authorised it on 2 April 1984; FDA authorised it on 15 July 2014.
Who is the marketing authorisation holder for Delsym in United States?
RB HLTH holds the US marketing authorisation.