FDA — authorised 19 March 1984
- Application: ANDA088042
- Marketing authorisation holder: CROWN LABS
- Status: approved
🇺🇸 Imodium Multi-Symptom Relief in United States
FDA authorised Imodium Multi-Symptom Relief on 19 March 1984
Marketing authorisations
FDA — authorised 26 June 1997
- Marketing authorisation holder: MCNEIL
- Status: approved
FDA — authorised 26 June 1997
- Application: NDA020606
- Marketing authorisation holder: J AND J CONSUMER INC
- Local brand name: IMODIUM MULTI-SYMPTOM RELIEF
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 30 November 2000
- Application: NDA021140
- Marketing authorisation holder: KENVUE BRANDS
- Local brand name: IMODIUM MULTI-SYMPTOM RELIEF
- Indication: TABLET — ORAL
- Status: approved
Imodium Multi-Symptom Relief in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Imodium Multi-Symptom Relief approved in United States?
Yes. FDA authorised it on 19 March 1984; FDA authorised it on 26 June 1997; FDA authorised it on 26 June 1997.
Who is the marketing authorisation holder for Imodium Multi-Symptom Relief in United States?
CROWN LABS holds the US marketing authorisation.