FDA — authorised 25 November 1992
- Application: NDA020259
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: MEPRON
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mepron in United States
FDA authorised Mepron on 25 November 1992
Marketing authorisations
FDA — authorised 8 February 1995
- Application: NDA020500
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: MEPRON
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 July 2000
- Application: NDA021078
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: MALARONE PEDIATRIC
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2014
- Application: ANDA202960
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 27 May 2014
- Application: ANDA202362
- Marketing authorisation holder: MYLAN
- Status: approved
FDA — authorised 28 April 2017
- Application: ANDA207833
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 October 2017
- Application: ANDA209750
- Marketing authorisation holder: APOTEX
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 September 2018
- Application: ANDA209105
- Marketing authorisation holder: LUPIN
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 October 2018
- Application: ANDA210692
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 21 November 2018
- Application: ANDA209685
- Marketing authorisation holder: GLENMARK SPECLT
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 May 2019
- Application: ANDA210510
- Marketing authorisation holder: ABHAI LLC
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 March 2021
- Application: ANDA212918
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ATOVAQUONE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 October 2021
- Application: ANDA214272
- Marketing authorisation holder: PAI HOLDINGS
- Status: approved
Mepron in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Mepron approved in United States?
Yes. FDA authorised it on 25 November 1992; FDA authorised it on 8 February 1995; FDA authorised it on 14 July 2000.
Who is the marketing authorisation holder for Mepron in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.