FDA — authorised 19 November 2010
- Application: ANDA090562
- Marketing authorisation holder: MICRO LABS
- Local brand name: MEFENAMIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 MEFENAMIC ACID in United States
FDA authorised MEFENAMIC ACID on 19 November 2010
Marketing authorisations
FDA — authorised 22 July 2011
- Application: ANDA091322
- Marketing authorisation holder: LUPIN LTD
- Local brand name: MEFENAMIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 February 2013
- Application: ANDA090359
- Marketing authorisation holder: MPP PHARMA
- Local brand name: MEFENAMIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 June 2014
- Application: ANDA091608
- Marketing authorisation holder: AJENAT PHARMS
- Local brand name: MEFENAMIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 September 2020
- Application: ANDA209209
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MEFENAMIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
MEFENAMIC ACID in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is MEFENAMIC ACID approved in United States?
Yes. FDA authorised it on 19 November 2010; FDA authorised it on 22 July 2011; FDA authorised it on 5 February 2013.
Who is the marketing authorisation holder for MEFENAMIC ACID in United States?
MICRO LABS holds the US marketing authorisation.