FDA — authorised 1 March 1956
- Application: NDA010151
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: DILANTIN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Dilantin in United States
FDA authorised Dilantin on 1 March 1956
Marketing authorisations
FDA — authorised 16 July 1975
- Application: ANDA084307
- Marketing authorisation holder: HIKMA
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1976
- Application: ANDA084349
- Marketing authorisation holder: VIATRIS
- Local brand name: DILANTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 1978
- Application: ANDA080259
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PROMPT PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
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 13 October 1987
- Application: ANDA089501
- Marketing authorisation holder: MARSAM PHARMS LLC
- 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 13 October 2022
- Application: ANDA213834
- Marketing authorisation holder: UNICHEM
- Status: approved
FDA — authorised 3 August 2023
- Application: ANDA040765
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA088711
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENYTEX
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA089900
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: PHENYTOIN SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
Pricing & reimbursement
- annual_list: USD 80000.00 per year
Dilantin 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 Dilantin approved in United States?
Yes. FDA authorised it on 1 March 1956; FDA authorised it on 16 July 1975; FDA authorised it on 27 August 1976.
Who is the marketing authorisation holder for Dilantin in United States?
PARKE DAVIS holds the US marketing authorisation.
What does Dilantin cost in United States?
annual_list: USD 80000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.