FDA — authorised 24 July 2002
- Status: approved
🇺🇸 Zelnorm in United States
FDA authorised Zelnorm on 24 July 2002
Marketing authorisations
FDA — authorised 24 July 2002
- Application: NDA021200
- Marketing authorisation holder: ALFASIGMA
- Local brand name: ZELNORM
- Indication: TABLET — ORAL
- Status: approved
Zelnorm in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Zelnorm approved in United States?
Yes. FDA authorised it on 24 July 2002; FDA authorised it on 24 July 2002.
Who is the marketing authorisation holder for Zelnorm in United States?
Marketing authorisation holder not available in our data.