FDA — authorised 18 January 1974
- Status: approved
🇺🇸 Moban in United States
FDA authorised Moban on 18 January 1974
Marketing authorisations
FDA — authorised 18 January 1974
- Application: NDA017111
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MOBAN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 December 1979
- Application: NDA017938
- Marketing authorisation holder: ENDO PHARMS
- Local brand name: MOBAN
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 22 January 2025
- Application: ANDA090453
- Marketing authorisation holder: EPIC PHARMA LLC
- Indication: Labeling
- Status: approved
The FDA approved Moban, manufactured by EPIC PHARMA LLC, for labeling on 22 January 2025. This approval was granted through the standard expedited pathway. The application number for this approval is ANDA090453.
Moban 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 Moban approved in United States?
Yes. FDA authorised it on 18 January 1974; FDA authorised it on 18 January 1974; FDA authorised it on 28 December 1979.
Who is the marketing authorisation holder for Moban in United States?
Marketing authorisation holder not available in our data.