FDA — authorised 22 December 2005
- Application: ANDA077648
- Marketing authorisation holder: ROXANE
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Zonegran in United States
FDA authorised Zonegran on 22 December 2005 · 2,489 US adverse-event reports
Marketing authorisations
FDA — authorised 22 December 2005
- Application: ANDA077644
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077645
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077647
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077635
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077636
- Marketing authorisation holder: GRANULES
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077637
- Marketing authorisation holder: RISING
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077639
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077641
- Marketing authorisation holder: ANI PHARMS
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2005
- Application: ANDA077642
- Marketing authorisation holder: APOTEX
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 2006
- Application: ANDA077651
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 March 2006
- Application: ANDA077634
- Marketing authorisation holder: SUN PHARM INDS (IN)
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 April 2006
- Application: ANDA077650
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 2006
- Application: ANDA077813
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 October 2006
- Application: ANDA077625
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 January 2021
- Application: ANDA214492
- Marketing authorisation holder: UNICHEM
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 May 2025
- Application: ANDA219507
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ZONISAMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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: 27 March 2025 – 27 March 2026
- Total reports: 2,489
Most-reported reactions
- Seizure — 471 reports (18.92%)
- Convulsion — 346 reports (13.9%)
- Drug Ineffective — 322 reports (12.94%)
- Fatigue — 238 reports (9.56%)
- Headache — 210 reports (8.44%)
- Somnolence — 209 reports (8.4%)
- Nausea — 205 reports (8.24%)
- Dizziness — 187 reports (7.51%)
- Fall — 152 reports (6.11%)
- Drug Interaction — 149 reports (5.99%)
Zonegran 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 Zonegran approved in United States?
Yes. FDA authorised it on 22 December 2005; FDA authorised it on 22 December 2005; FDA authorised it on 22 December 2005.
Who is the marketing authorisation holder for Zonegran in United States?
ROXANE holds the US marketing authorisation.