FDA — authorised 6 January 1953
- Marketing authorisation holder: PARKE DAVIS
- Status: approved
🇺🇸 Phenytoin Sodium in United States
FDA authorised Phenytoin Sodium on 6 January 1953
Marketing authorisations
FDA — authorised 11 May 1979
- Application: ANDA085894
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 May 1985
- Application: ANDA089003
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 1987
- Application: ANDA089744
- Marketing authorisation holder: HOSPIRA
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 1992
- Application: ANDA089779
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 1998
- Application: ANDA040298
- Marketing authorisation holder: MYLAN
- Local brand name: PHENYTEK
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 September 2006
- Application: ANDA040573
- Marketing authorisation holder: ACELLA
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 January 2010
- Application: ANDA040731
- Marketing authorisation holder: SUN PHARM INDS
- Indication: Labeling
- Status: approved
FDA — authorised 26 December 2013
- Application: ANDA084349
- Marketing authorisation holder: VIATRIS
- Indication: Labeling
- Status: approved
FDA — authorised 20 March 2015
- Application: ANDA040521
- Marketing authorisation holder: TARO
- Indication: Labeling
- Status: approved
FDA — authorised 28 September 2020
- Application: ANDA084307
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 3 August 2023
- Application: ANDA040765
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
Phenytoin Sodium in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Phenytoin Sodium approved in United States?
Yes. FDA authorised it on 6 January 1953; FDA authorised it on 11 May 1979; FDA authorised it on 31 May 1985.
Who is the marketing authorisation holder for Phenytoin Sodium in United States?
PARKE DAVIS holds the US marketing authorisation.