FDA — authorised 30 December 1985
- Application: NDA018873
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: MEXITIL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Mexitil in United States
FDA authorised Mexitil on 30 December 1985
Marketing authorisations
FDA — authorised 30 December 1985
- Status: approved
FDA — authorised 22 June 1998
- Application: ANDA074450
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 July 2020
- Application: ANDA213500
- Marketing authorisation holder: CROSSMEDIKA SA
- Status: approved
FDA — authorised 9 November 2022
- Application: ANDA216463
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 29 August 2023
- Application: ANDA202111
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 23 March 2026
- Application: ANDA219987
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Status: approved
Mexitil 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 Mexitil approved in United States?
Yes. FDA authorised it on 30 December 1985; FDA authorised it on 30 December 1985; FDA authorised it on 22 June 1998.
Who is the marketing authorisation holder for Mexitil in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.