FDA — authorised 8 March 1954
- Application: NDA009170
- Marketing authorisation holder: VALEANT
- Local brand name: MYSOLINE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mysoline in United States
FDA authorised Mysoline on 8 March 1954
Marketing authorisations
FDA — authorised 8 March 1954
- Marketing authorisation holder: VALEANT
- Status: approved
FDA — authorised 1 December 1978
- Application: ANDA084903
- Marketing authorisation holder: LANNETT
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 February 1979
- Application: ANDA083551
- Marketing authorisation holder: WATSON LABS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 February 2005
- Application: ANDA040586
- Marketing authorisation holder: OXFORD PHARMS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 2005
- Application: ANDA040626
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 July 2006
- Application: ANDA040667
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 February 2008
- Application: ANDA040717
- Marketing authorisation holder: IMPAX LABS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 April 2008
- Application: ANDA040866
- Marketing authorisation holder: AMNEAL PHARM
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2008
- Application: ANDA040862
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 June 2022
- Application: ANDA214896
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 January 2024
- Application: ANDA218366
- Marketing authorisation holder: CARNEGIE
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085052
- Marketing authorisation holder: WATSON LABS
- Local brand name: PRIMIDONE
- Indication: TABLET — ORAL
- Status: approved
Mysoline 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 Mysoline approved in United States?
Yes. FDA authorised it on 8 March 1954; FDA authorised it on 8 March 1954; FDA authorised it on 1 December 1978.
Who is the marketing authorisation holder for Mysoline in United States?
VALEANT holds the US marketing authorisation.