FDA — authorised 6 January 1953
- Application: NDA008762
- Marketing authorisation holder: VIATRIS
- Local brand name: DILANTIN-30
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 valproic acid (VPA) in United States
FDA authorised valproic acid (VPA) on 6 January 1953
Marketing authorisations
FDA — authorised 25 September 1992
- Application: ANDA089892
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: PHENYTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 31 January 2001
- Application: ANDA040342
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: PHENYTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 19 April 2002
- Application: ANDA040420
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: PHENYTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 March 2004
- Application: ANDA040521
- Marketing authorisation holder: TARO
- Local brand name: PHENYTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 December 2012
- Application: ANDA200691
- Marketing authorisation holder: RISING
- Local brand name: PHENYTOIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 28 November 2014
- Application: ANDA040884
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: PHENYTOIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
Other Neurology approved in United States
Frequently asked questions
Is valproic acid (VPA) approved in United States?
Yes. FDA authorised it on 6 January 1953; FDA authorised it on 25 September 1992; FDA authorised it on 31 January 2001.
Who is the marketing authorisation holder for valproic acid (VPA) in United States?
VIATRIS holds the US marketing authorisation.