FDA — authorised 22 September 1980
- Application: NDA018021
- Marketing authorisation holder: LEDERLE
- Local brand name: ASENDIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Amoxan in United States
FDA authorised Amoxan on 22 September 1980
Marketing authorisations
FDA — authorised 28 June 1991
- Application: ANDA072879
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: AMOXAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 1992
- Application: ANDA072691
- Marketing authorisation holder: WATSON LABS
- Local brand name: AMOXAPINE
- Indication: TABLET — ORAL
- Status: approved
Amoxan 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 Amoxan approved in United States?
Yes. FDA authorised it on 22 September 1980; FDA authorised it on 28 June 1991; FDA authorised it on 28 August 1992.
Who is the marketing authorisation holder for Amoxan in United States?
LEDERLE holds the US marketing authorisation.