FDA — authorised 18 December 1986
- Application: ANDA089441
- Marketing authorisation holder: ANI PHARMS
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Extended Phenytoin Sodium in United States
FDA authorised Extended Phenytoin Sodium on 18 December 1986 · 143 US adverse-event reports
Marketing authorisations
FDA — authorised 28 December 1998
- Application: ANDA040298
- Marketing authorisation holder: MYLAN
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 2003
- Application: ANDA040435
- Marketing authorisation holder: ANI PHARMS
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 September 2006
- Application: ANDA040684
- Marketing authorisation holder: TARO
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 December 2006
- Application: ANDA040621
- Marketing authorisation holder: SUN PHARM INDS (IN)
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 December 2007
- Application: ANDA040759
- Marketing authorisation holder: WOCKHARDT
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 2008
- Application: ANDA040732
- Marketing authorisation holder: WOCKHARDT USA
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 2008
- Application: ANDA040731
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: EXTENDED PHENYTOIN SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 22 April 2025 – 22 April 2026
- Total reports: 143
Most-reported reactions
- Convulsion — 33 reports (23.08%)
- Anticonvulsant Drug Level Decreased — 18 reports (12.59%)
- Anticonvulsant Drug Level Below Therapeutic — 16 reports (11.19%)
- Grand Mal Convulsion — 16 reports (11.19%)
- Pharmaceutical Product Complaint — 16 reports (11.19%)
- Drug Ineffective — 13 reports (9.09%)
- Stevens-Johnson Syndrome — 11 reports (7.69%)
- Fall — 8 reports (5.59%)
- Pruritus — 6 reports (4.2%)
- Toxic Epidermal Necrolysis — 6 reports (4.2%)
Other Neurology approved in United States
Frequently asked questions
Is Extended Phenytoin Sodium approved in United States?
Yes. FDA authorised it on 18 December 1986; FDA authorised it on 28 December 1998; FDA authorised it on 20 June 2003.
Who is the marketing authorisation holder for Extended Phenytoin Sodium in United States?
ANI PHARMS holds the US marketing authorisation.